以 下 的 文 件 是 一 份 关 於 部 份 有 潜 在 危 险 的 医 疗 仪 器 安 全 资 讯 的 摘 要 ， 它 只 可 作 为 快 速 参 考 之 用 ， 并 不 应 被 视 为 完 全 及 最 新 。 详 情 请 参 阅 有 关 的 资 讯 来 源 及 联 络 你 的 供 应 商 。 ( 修 订 於 2012 年 5 月 29 日 )
| Summary for the Current Year |
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| Summary for Previous Years |
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[29 May 2012] Medical Device Safety Alert: Natus Medical Olympic Cool-Cap® System |
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[29 May 2012] Medical Device Safety Alert: Edwards Lifesciences Heart Valves |
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[28 May 2012] Medical Device Safety Alert: Baxa Abacus Total Parenteral Nutrition Calculation Software |
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[25 May 2012] Medical Device Safety Alert: Capatex Neonatal Endotracheal Tube SCP Clamp/Holders |
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[24 May 2012] Medical Device Safety Alert: Moog Curlin Intravenous Administration Sets |
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[23 May 2012] Medical Device Safety Alert: Biocompatibles Bead Block Embolization Agent |
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[22 May 2012] Medical Device Safety Alert: Schiller Medical FRED easy & FRED easy Life Defibrillators |
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[22 May 2012] Medical Device Safety Alert: Covidien Legendair™ and Supportair™ Portable Ventilators |
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[ 18 May 2012] Medical Device Safety Alert: Covidien, Roticulator™ Single Use Stapler |
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[21 May 2012] Medical Device Safety Alert: Abbott Molecular Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials |
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[ 18 May 2012] Medical Device Safety Alert: Covidien, Roticulator™ Single Use Stapler |
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[18 May 2012] Medical Device Safety Alert: Varian TrueBeam and TrueBeam STx Versions 1.0 through 1.5 |
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[17 May 2012] Medical Device Safety Alert: Endeavour Quad (4 X Point) Walking Stick |
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[17 May 2012] Medical Device Safety Alert: Ormco Enlight Unidose |
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[16 May 2012] Medical Device Safety Alert: DePuy Side Fire Needles, part of Confidence Spinal Cement System™ |
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[15 May 2012] Medical Device Safety Alert: BOMImed. Disposable Resuscitators |
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[14 May 2012] Medical Device Safety Alert: Terumo Sarns™ Antegrade Cardioplegia Cannula |
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[10 May 2012] Medical Device Safety Alert: Endoscope Accessory Holder |
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[09 May 2012] Medical Device Safety Alert: Hager & Werken Brilliant Mouth Mirror No. 4 |
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[08 May 2012] Medical Device Safety Alert: Advanced Sterilization Products STERRAD® CYCLESURE® 24 Biological Indicators |
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[07 May 2012] Medical Device Safety Alert: Hill-Rom Affinity® Four Birthing Bed |
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[03 May 2012] Medical Device Safety Alert: DePuy Cemented, Polished and Cobalt Chromium Alloy Hip Stems |
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[03 May 2012] Medical Device Safety Alert: Pioneer Surgical Nubac Trial Inserter ˉ 43-TRL-INSERTER |
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[03 May 2012] Medical Device Safety Alert: Elekta XVI R4.5 systems |
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[03 May 2012] Medical Device Safety Alert: Hsin Ten Electro Reflex Energizer |
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[03 May 2012] Medical Device Safety Alert: Invacare TDX SP Power Wheelchair |
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[03 May 2012] Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillators, Model M3536A |
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[30 April 2012] Field Safety Notice: BD Phoenix™ System Software and BD Phoenix™ Update Disks |
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[30 April 2012] Field Safety Notice: Pace Medical MICRO-PACE™ dual-chamber temporary cardiac pacemaker, REF 4580 |
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[27 April 2012] Field Safety Notice: BD PrepMate™ Syringing Pipette |
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[25 April 2012] Field Safety Notice: MEDRAD® Continuum Pump and Tubing Set |
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[23 April 2012] MHRA issues updates on the use of injectable dermal filler, Macrolane for breast augmentation |
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[23 April 2012] Field Safety Notice: Smith & Nephew, Inc. Trauma Pins and Drills |
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[23 April 2012] Field Safety Notice: Baxa EVA TPN bags |
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[20 April 2012] Field Safety Notice: Elekta MLCi and MLCi2 radiation heads |
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[20 April 2012] Field Safety Notice: Baxa EVA TPN bags |
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[20 April 2012] Field Safety Notice: Ergolet Hera II Bathing and Toilet Chair |
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[19 April 2012] Field Safety Notice: Other-Sonic Generic Ultrasound Transmission Gel |
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[18 April 2012] Field Safety Notice: 4D Integrated Treatment Console (4DITC) versions 8.1.3 to 8.8 |
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[18 April 2012] Field Safety Notice: 4D Integrated Treatment Console (4DITC) v8.6 or 8.8 in combination with treatment planning systems |
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[17 April 2012] Field Safety Notice: Damon 3MX Bicuspid Brackets |
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[16 April 2012] MHRA Medical Device Alert: Oral swabs with a foam head |
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[12 April 2012] Field Safety Notice: St. Jude Medical QuickSite® and QuickFlex® Left Ventricular CRT Leads [Models 1056T, 1058T, 1156T and 1158T] |
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[12 April 2012] Field Safety Notice: IDEV Technologies SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F) |
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[5 April 2012] Field Safety Notice: Animas OneTouch Ping Insulin Pump |
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[ 3 April 2012] MHRA issued new advice about metal-on-metal total hip replacements: MITCH TRH acetabular cups/MITCH TRH modular heads (Finsbury Orthopaedics) implanted with uncemented Accolade femoral stems (Stryker Orthopaedics) |
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[30 March 2012] Field Safety Notice: Smith & Nephew 560P High Definition Camera Control Unit |
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[29 March 2012] Field Safety Notice: Bristol-Myers Squibb ViaSpan |
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[23 March 2012] Field Safety Notice: Philips HeartStart XL+ (861290) Defibrillator/Monitor |
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[22 March 2012] Field Safety Notice: Hospira GemStar™ Bolus Cord used with Gemstar™ Pump |
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[21 March 2012] Field Safety Notice: Boston Scientific Imager Angiographic Catheter (Peripheral Intervention) |
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[21 March 2012] Field Safety Notice: Boston Scientific Imager™ II Catheter (Urology) |
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[21 March 2012] Field Safety Notice: Terumo® Advanced Perfusion System 1 |
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[21 March 2012] Field Safety Notice: Philips HeartStart MRx monitor/defibrillator |
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[21 March 2012] Field Safety Notice: Roche Process Systems Manager Software Version 2.02.02c |
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[21 March 2012] Field Safety Notice: LifeScan OneTouch® Verio® IQ Blood Glucose Meters |
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[20 March 2012] Field Safety Notice: Medtronic SynchroMed® II Pump |
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[20 March 2012] Field Safety Notice: Varian FastPlan treatment planning system |
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[20 March 2012] Field Safety Notice: Varian Eclipse™ Treatment Planning System |
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[20 March 2012] Field Safety Notice: Brainlab BrainSCAN and iPlan RT treatment planning software versions |
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[19 March 2012] Field Safety Notice: Varian Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6 |
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[16 March 2012] Field Safety Notice: Abbott Molecular HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0 |
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[14 March 2012] Field Safety Notice: Medtronic ATLANTIS™ / PREMIER® / VERTEX® Adjustable Drill Stop |
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[14 March 2012] Field Safety Notice: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm |
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[14 March 2012] Field Safety Notice: Boston Scientific ICD TELIGEN, Model Nos.: F102, F103, F110, F111 and CRT-D COGNIS, Model Nos.: P107 and P108 |
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[9 March 2012] Field Safety Notice: B. Braun Infusomat Space Pump - US Version Infusion pump |
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[9 March 2012] Field Safety Notice: Terumo CDI™ 500 Blood Parameter Monitoring System |
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[9 March 2012] Field Safety Notice: Terumo Soft-Flow© Aortic Cannula with angled tip |
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[8 March 2012] Field Safety Notice: BIOS Rollator |
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[8 March 2012] Field Safety Notice: Etac Avant, Avant LW and Salsa |
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[8 March 2012] Field Safety Notice: Soloist™ Single Needle Electrode |
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[7 March 2012] Field Safety Notice: SD Bioline HIV-1/2 v3.0 |
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[7 March 2012] Field Safety Notice: Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0 |
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[7 March 2012] Field Safety Notice: 4D Integrated Treatment Console and TrueBeam |
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[6 March 2012] Field Safety Notice: HeartStart FR3 Automated External Defibrillators |
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[6 March 2012] Field Safety Notice: Carry Case used with the HeartStart FR3 Automated external defibrillator (AED) |
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[29 February 2012] MHRA updated recommendations for the management of patients implanted with metal-on-metal hip replacements |
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[29 February 2012] Field Safety Notice: Scottcare TeleSentry Model TS01 |
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[28 February 2012] Field Safety Notice: SonRtip endocardial pacing lead with contractility sensor, model PS55D |
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[28 February 2012] Field Safety Notice: Thoratec HeartMate IIR Left Ventricular Assist System |
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[23 February 2012] Field Safety Notice: SybronEndo K3 Gutta Percha |
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[23 February 2012] Field Safety Notice: SybronEndo Buchanan Medium Pluggers |
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[21 Febraury 2012] Field Safety Notice: Biosense Webster Carto® 3 Systems |
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[21 Febrauary 2012] Field Safety Notice: Helping Hand Turntable MK 6, Skyframe Hoist System |
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[16 February 2012] Field Safety Notice: The Nemschoff Perinatal Bassinet Products (Models: BSNT/01, BSNT/02, BSNT/03, BSNT/04) |
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[14 February 2012] Field Safety Notice: Philips IntelliVue patient monitors |
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[14 February 2012] Field Safety Notice: Salter Labs 7600 Bubble Humidifier |
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[14 February 2012] Field Safety Notice: Boston Scientific Wingspan™ Stent System with Gateway™ PTA Balloon Catheter |
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[13 February 2012] Field Safety Notice: BD PrepStain™ Vacuum Pumps |
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[9 February 2012] Field Safety Notice: Zoll Pedi-Padz Reduced Energy Electrode, Model # 8900-0401 |
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[6 February 2012] Field Safety Notice: Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B |
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[1 February 2012] Field Safety Notice: Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System |
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[1 February 2012] Field Safety Notice: Abbott Molecular Bar Code Scanner User's Guide |
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[1 February 2012] Field Safety Notice: TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore |
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[31 January 2012] Statement on Metal-on-Metal Hip Replacement Implants issued by the Medicines and Healthcare Products Regulatory Agency (MHRA), UK |
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[26 January 2012] Field Safety Notice: Recall of CareFusion Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License |
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[26 January 2012] Field Safety Notice: Biomet Microfixation Sternalock Blu Implant Tray |
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[26 January 2012] Field Safety Notice: Terumo CDI™ Blood Parameter Monitoring System 500 |
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[16 January 2012] Field Safety Notice: Recall of Covidien Duet TRS™ Universal Straight and Articulating Single Use Loading Units |
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[13 January 2012] FDA Class I Recall: Respironics Trilogy 100 Ventilators |
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[13 January 2012] Field Safety Notice: TerumoR Advanced Perfusion System 1 |
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[12 January 2012] Field Safety Notice: Given Imaging Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles) |
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[10 January 2012] MHRA Field Safety Notice: SynCardia Companion 2 Driver System |
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[4 January 2012] Field Safety Notice: HeartWare® Ventricular Assist System |
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[4 January 2012] Field Safety Notice: SynCardia Freedom Driver System |
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[28 December 2011] Field Safety Notice: Sierra Scientific Instruments ManoShield™ AR |
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[20 December 2011] Field Safety Notice: Update of the Instructions for Use of DLPR Single Stage Venous Cannulae |
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[14 December 2011] Field Safety Notice: Elekta Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Models, All lot no.) |
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[13 December 2011] Field Safety Notice: Amendments to instructions for use of CERAGEM-E Massage Bed |
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[13 December 2011] Field Safety Notice: Smiths Medical Graseby MR10 Neonatal Respiration Monitor |
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[8 December 2011] Field Safety Notice: Bausch & Lomb Crystalens® Accommodating Posterior Chamber Intraocular |
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[6 December 2011] Field Safety Notice: 4Care AG's SH-System Monatslinsen contact lenses |
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[6 December 2011] Field Safety Notice: Metrex Research Pinnacle Syringe Sleeves |
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[5 December 2011] Field Safety Notice: CLR Medicals International Inc., Visco Supreme |
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[2 December 2011] Field Safety Notice: Beavers Dental FG 1/2 Burs |
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[2 December 2011] Field Safety Notice: Pentron Clinical Correct Plus Berry Putty Auto Mix |
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[2 December 2011] Field Safety Notice: Pentron Clinical Artiste Nano-Hybrid Flowable Composite |
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[2 December 2011] Field Safety Notice: Beavers Dental LA 5 Burs |
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[29 November 2011] Field Safety Notice: Abbott Vascular RX Accunet Embolic Protection System |
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[29 November 2011] Field Safety Notice: Sybron Dental Specialties Freedom Cordless LED Headlight |
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[29 November 2011] Field Safety Notice: Cordis SUPER TORQUER MB Angiographic Catheter |
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[28 November 2011] Field Safety Notice: Medtronic Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006, 62000, 62006) |
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[25 November 2011] Field Safety Notice: Varian C-Series Clinac or Trilogy, versions 7.x and 8.x |
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[25 November 2011] Field Safety Notice: Impulse Dynamics OPTIMIZERR III Implantable Pulse Generator |
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[23 November 2011] Field Safety Notice: Terumo CVS Sarns™ Sternal Saw I System |
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[23 November 2011] MHRA Field Safety Notice: Spacelabs Healthcare hook-up kits containing non-sterile alcohol prep pads |
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[22 November 2011] MHRA Field Safety Notice: Mindray V series patient monitor |
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[17 November 2011] Medical Device Recall : Coloplast Catheter Valve |
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[17 November 2011] Field Safety Notice: Varian OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0 |
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[17 November 2011] Field Safety Notice: Varian Eclipse Release 10 with ARIAT Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34) |
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[15 November 2011] Field Safety Notice: Brainlab BrainSCAN version 5.31 and 5.32 |
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[15 November 2011] Health Canada Type II Recall: Sorin CRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347) |
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[15 November 2011] MHRA Field Safety Notice: Handicare Puma, Beatle, Alex and Ibis XP power wheelchairs |
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[15 November 2011] Health Canada Type I Recall: Zevex Ambulatory Infusion Pumps Painsmart IOD, 6000 CMS, and 4000 CMS |
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[15 November 2011] MHRA FSN Safety Alert: Spacelabs Healthcare ABP Monitor, Model 90217A |
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[14 November 2011] Medical Device Recall: Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths |
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[8 November 2011] Field Safety Notice: Varian TrueBeam and TrueBeam STx |
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[1 November 2011] Product Recall: Synthes A2FN Reamer |
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[31 October 2011] Field Safety Notice: Boston Scientific SCS Remote Control (RC), Charger, External Trial Stimulator, Trial Patient Belt & Charger Belt |
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[28 October 2011] Field Safety Notice: Boston Scientific COGNISR, TELIGENR, INCEPTATM, PUNCTUATM, and ENERGENTM CRT-Ds and ICDs, and LATITUDER remote patient monitoring system |
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[24 October 2011] Field Safety Notice: Drager Delta, Delta XL, Vista XL, Gamma XXL and Kappa |
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[24 October 2011] Field Safety Notice: Immucor Gamma Complement Control Cells, lot 34161 |
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[21 October 2011] FDA Field Safety Notice: Cardiac Science Corporation Powerheart Automated External Defibrillator (AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440 |
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[21 October 2011] TGA Class II Recall: Oto-Ease ear lubricant |
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[21 October 2011] FDA Class I Recall: CareFusion EnVe Ventilators |
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[19 October 2011] Field Safety Notice: Elekta XVI 4.5 and 4.6 |
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[18 October 2011] Urgent Field Safety Notice: "Choice for Health" Various Bandages |
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[18 October 2011] Field Safety Notice: Boston Scientific TWISTERTM Rotatable Polyp Retrieval Device |
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[17 October 2011] Urgent Field Safety Notice: Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25 and 10.0.28) |
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[14 October 2011] FDA Educational Materials: Decorative Contact Lenses |
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[13 October 2011] Urgent Product Recall: BD Oral Syringe with Syringe Tip Caps |
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[13 October 2011] Urgent Field Safety Notice: Abbott m2000sp Instrument |
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[13 October 2011] Field Safety Notice: InfinityR Acute Care System (IACS) Monitoring Solution
with software versions VG1, VG1.2 and VG1.3 |
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[11 October 2011] MHRA Field Safety Notice: Breathing System Components |
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[11 October 2011] MHRA Field Safety Notice: Octopus-3 x Anti-reflux Valves + Clamps |
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[7 October 2011] Urgent Field Safety Notice: Varian FrameArray Module HZ7 and Floorstand HZ5 |
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[6 October 2011] Health Canada Type II Recall: Warmair Model 134 |
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[4 October 2011] Field Safety Notice: Hospira All Plum A+ family of Infusers |
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[4 October 2011] Field Safety Notice: Synthes Anspach Single-use Cutting Burs and Irrigation Clips |
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[30 September 2011] Field Safety Notice: Terumo CVS CDI Blood Parameter Monitoring System 500 |
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[30 September 2011] MHRA Medical Device Alert: Reusable laryngoscope handles |
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[28 Sept 2011] Voluntary Product Recall: Bausch & Lomb Soflens 59, lot W12010319 |
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[23 Sept 2011] Urgent Field Safety Notice: Penlon CrystalR Metal Disposable Blades (Mac 3 and Mac 4) |
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[22 Sept 2011] Field Safety Alert: Gemstar docking station (model number:13075) |
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[20 Sept 2011] FDA Class I Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits |
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[15 Sept 2011] Urgent Field Safety Notice: Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators |
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[14 Sept 2011] Voluntary Recall Notification: Cochlear Nucleus CI500 cochlear implant range |
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[8 September 2011] Urgent Field Safety Notice: RT Chart function of ARIA™ |
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[7 September 2011] Field Safety Notice: Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor |
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[2 September 2011] FDA Class I Recall: Boston Scientific Innova™ Self-Expanding Stent System |
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[31 August 2011] Robinson Healthcare Cotton Gauze Tissue BP 45x90cm |
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[30 August 2011] Abbott Diagnostic Clinical Chemistry Alkaline Phosphatase Reagent |
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[29 August 2011] Urgent Field Safety Notice: Eclipse 10 (Client builds 10.0.28 and 10.0.34) |
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[18 August 2011] 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1 |
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[18 August 2011] Medical Device Removal: Terumo Level Sensor II Pads |
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[15 August 2011] Boston Scientific Expect™ Endoscopic Ultrasound Aspiration Needle |
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[9 August 2011] Boston Scientific Katzen™ Infusion Wire |
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[5 August 2011] Arrow NextStep Antegrade Chronic Hemodialysis Catheter manufactured between April 14, 2011 and May 9, 2011 |
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[4 August 2011] Use of Brainlab Skull Reference Base in combination with KLS Martin Cross-Drive screws |
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[4 August 2011] Philips Allura Xper Systems - Allura Xper FD10 (F/C), Allura Xper FD10/10 (incl. OR table), Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/20 and Allura CV20 |
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[4 August 2011] GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits |
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[3 Aug 2011] FDA Class I Recall: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System |
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[27 July 2011] Coseal Surgical Sealant |
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[26 July 2011] 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3 |
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[20 July 2011] Field Safety Notice: Boston Scientific Resolution® II Clip |
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[20 July 2011] TomoTherapy Treatment Systems Hi·Art versions 4.0.x, and HD versions 1.0.x |
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[20 July 2011] Abbott Medical Optics (AMO) STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30 |
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[17 July 2011] Thermo Fisher Scientific, Thermo Scientific Microm HM355S |
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[17 July 2011] Boston Scientific PROMUS ElementTM Everolimus-Eluting Coronary Stent System |
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[14 July 2011] FDA Updates on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse |
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[14 July 2011] Alert on product recall : Banitore Basic Dressing Pack |
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[11 July 2011] Smith & Nephew, Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length. |
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[8 July 2011] Varian Eclipse Treatment Planning System: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), Model: H48 |
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[7 June 2011] GE Healthcare Power supply for TruSat Pulse Oximeter |
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[24 May 2011] Beckman Coulter Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell (Model affected: LX20 - 466200, LX20 PRO - 476100, LXi 725 - 476501) |
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[13 May 2011] Nova StatStrip Glucose Hospital Monitoring System |
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[13 May 2011] Siemens LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential |
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[3 May 2011] Roche Diagnostics Ltd. Process System Manager (PSM) Software |
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[26 April 2011] EclipseTM Treatment Planning System |
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[21 April 2011] Sunrise Medical Quickie Neon Swing-Away manual wheelchairs |
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[14 April 2011] Penumbra Coil 400 |
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[14 April 2011] iCAD AxxentR FlexiShield Mini, Model F5300 |
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|
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[13 April 2011] Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD |
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[30 March 2011] Smiths Medical Level 1 Normothermic IV administration set DI-65HL, DI-75 and DI150 |
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[23 March 2011] Kerr Corporation OptiBond FL Adhesive Refill (Model no. 25882) |
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[23 March 2011] BioLytical Laboratories INSTI 24 Test Kit without Support Materials (Model no. 62013) |
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[23 March 2011] Fresenius Medical Care Optiflux F250NRe Dialyzers |
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[18 March 2011] Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M. tuberculosis Complex, ACCUPROBE M. avium Complex |
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[15 March 2011] Unomedical (a ConvaTec company) Endotracheal (ET) tubes, adult and paediatric sizes |
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|
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[15 February 2011] Invitrogen HLA (human leukocyte antigen) tissue typing kits |
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|
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[10 February 2011] Philips HeartStart MRx (M3535A/M3536A) with software versions F.01.00 or F.01.01 |
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[7 February 2011] Maquet Cardiovascular, LLC Heartstring II Proximal Seal System |
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[7 February 2011] Arstasis Inc One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010 |
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[27 January 2011] 美国食品药物管理局指出乳房植入物和一种罕见的癌症之间可能有关联 |
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[20 January 2011] B Braun Outlook 400ES Safety Infusion System |
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[20 January 2011] Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9 and 03-2795-7 |
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[7 January 2011] Unomedical Nasogastric feeding tube |
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[7 January 2011] Triad Group Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks |
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[23 December 2010] Abbott Glucose Test Strips Precision Xceed Pro; Precision Xtra;
Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima |
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|
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[23 December 2010] SCC Soft Computer SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16 |
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[23 December 2010] BioMerieux Inc VITEK 2 Gram Negative Susceptibility Card |
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[22 December 2010] Varian Medical Clinac Linear Accelerator, Trilogy Radiotherapy Delivery System, Clinac IX Radiotherapy Delivery System, Novalis TX Linear Accelerator and Acuity Radiation Therapy Stimulator |
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[22 December 2010] Fresenius Medical Care Combiset Blood Volume Monitor Bloodline |
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[22 December 2010] Fresenius Red Blood Cell (RBC) Set (catalog number 9007601) |
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|
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[10 December 2010] Tyco Healthcare Puritan Bennett 840 ventilator |
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|
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[10 December 2010] Hospira Symbiq One-Channel Infuser LIST No. 16026; Symbiq Two-Channel Infuser, List No. 16027 |
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|
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[30 November 2010] Varian C-Series Clinacs (Models H14, H18, H29) |
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[24 November 2010] Micromedics Surgical Sealant Dispensers; Micromedics Nasal Septal Buttons; Otological Ventilation Tubes |
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[20 November 2010] Roche Diagnostics A) Factor V Leiden Kit for Light Cycler V2, B) Factor II (Prothrombin), C) MagNA Pure LC 2.0 Instrument |
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[6 November 2010] Confluent Surgical Pleuraseal Lung Sealant System |
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[14 October 2010] Multi-Med Huber needles |
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[13 October 2010] CareFusion Alaris PC Unit Model 8000 |
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[13 October 2010] CareFusion Alaris PC Unit Model 8015 |
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[29 September 2010] Roche Diagnostics Cobas IT 3000 Software, Cat. No. 05161401001, Version 2.03.09 |
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|
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[29 September 2010] Lifescan A) OneTouch DataLink Data Management System,
B) OneTouch DataLink Management System |
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|
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[29 September 2010] Beckman Coulter Clinical Chemistry Analyzer A) AU5400, B) AU2700, C) AU400, AU400E, D) AU600, AU640, AU640E, E) AU680, F) AU480 |
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|
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[29 September 2010] James Spencer All Ventnor mobile shower chairs |
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[21 September 2010] All brands Intravenous (IV) extension sets with multiple ports |
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|
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[17 September 2010] Kimal K-Flow Access Catheters; Kimal High Flow (HF) Haemodialysis Catheters; Kimal Right Atrial (KRA) Catheters |
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|
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[16 September 2010] Symbiq One- and Two- Channel Infuser. List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54 |
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[15 September 2010] Sequal Eclipse Oxygen System. (Lot: 073002972, 063005184, 073006282, 073000585, 073007840, 073006062, 073002301, 073004651,073003155,073004456) |
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[10 September 2010] Roche Diagnostics A) Tina-Quant D-Dimer Gen.2 for Cobas Integra and Cobas C-System B) Tina-Quant D-Dimer Gen.2 for Roche/Hitachi 917 and Modular P Analyzers C) Tina-Quant D-Dimer Gen.2 for Roche Cobas C111 Analyzers |
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[9 September 2010] AngioScore AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system |
| |
|
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[8 September 2010] DePuy ASR Hip Replacement Implants (Updated) |
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[7 September 2010] Various Manufacturer - IV Extension sets with multiple ports and vented caps |
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|
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[21 August 2010] Immuncor Panoscreen I, II & III |
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|
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[20 August 2010] St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838, 3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3110892, 3118797, 3107789, 3107790) |
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[14 August 2010] St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838, 3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3107789, 3107790) |
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[11 August 2010] Ikaria INOMAX DS drug-delivery systems |
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[31 Jul 2010] Rehabilitation Centre for Children Tilt Standing Frame |
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[31 July 2010] B. Braun AddEase Binary Connector |
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[30 July 2010] Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System. Medical device (Product codes: GXMRSA/SA-BC-10, Lot 00601, 00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102, 01301, 01302; Product code: GXMRSA/SA-BC-CE-10, Lot 01001, 01101, 01301) |
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[30 July 2010] Multi-Med 22ga x 1" Straight Huber Needle (Model number 10600218, Lot 9B020M), 22ga x 1" Right Angle Huber Needle (Model number 10600219, Lot 9B017M). |
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[3 July 2010] Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot Numbers: 00401, 00502, 00701, 00702, 00501) |
| |
|
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[19 June 2010] Ace Surgical Supply Calcium Sulfate Hemihydrate Kit, 1g (Model or Catalog#505-2001) and Calcium Sulfate Hemihydrate Kit, 0.5g (Model or Catalog#505-2002) |
| |
|
| |
[19 June 2010] Remington Disposable Surgical Extension Cable (Model or Catalog#
FL-601-97, Lot or Serial# 100701) |
| |
|
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[19 June 2010] Smith & Nephew Genesis II Resection Cutting Blocks (Model or Catalog # 71440116, 71440118) |
| |
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[10 June 2010] Sorin Paradym DR, CRT-D & CRT-D sonR ICD (Models:8550, 8750 & 8770) |
| |
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[9 June 2010] C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh labeled with C.R. Bard/Davol brand names (product no. 0112650, 0112660, 0112680, 0112720 Bard Flat Mesh with lot no. 48HVS036, 43APD007, HUSD0629, HURL0336, 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43FQD327) are not Bard-manufactured products |
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[1 June 2010] Philips HeartStart FR2+ Automated External Defibrillator |
| |
|
| |
[31 May 2010] Medtronic LIFEPAK 20 and LIFEPAK 20e Defibrillator/Monitors |
| |
|
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[28 May 2010] Stryker AVS (Adaptive Vertebral PEEK Spacer) TL Spacer Trial 7-18 (Product Ref: from 48389407 to 48389418) |
| |
|
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[20 May 2010] Terumo Sarns Disposable Centrifugal Pump (Cat. Nos. 164275 & 16427X) and Cardiovascular Procedure Kits containing pumps from affected lots |
| |
|
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[18 May 2010] Defibtech DBP-2800 Battery Packs used with DDU-100 series AEDs sold under the brand names Lifeline AED and ReviveR AED (serial no.: between 202001005 and 202005916, or between 206001001 and 206009871.) |
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[13 May 2010] Philips Heartstart FRx AED (Model 861304), Heartstart (HS1) Onsite AED (Model M5066A), Heartstart (HS1) Laerdal brand onsite AED (Model M5067A), HeartStart HS1 Defibrillator (Model M5068A) |
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|
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[12 May 2010] Heartware Ventricular Assist System Controller |
| |
|
| |
[11 May 2010] GE Healthcare CARESCAPE Monitor B850 version 1.0.1.13 and 1.0.2.1 |
| |
|
| |
[7 May 2010] Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570) |
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[7 May 2010] Varian Varisource iX Console |
| |
|
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[7 May 2010] Cook Medical Ciaglia Blue Dolphin and Ciaglia Blue Rhino Balloon Percutaneous Tracheostomy Introducer Set (with Shiley Percutaneous Tracheostomy Tube) |
| |
|
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[6 May 2010] St. Jude Medical Convert+ Model V-195 Implantable Cardioverter-Defibrillator |
| |
|
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[6 May 2010] Beckman Coulter Synchron Systems Modular Glucose (GLUCm) Reagent (Model 472500) |
| |
|
| |
[6 May 2010] Codman & Shurtleff (JNJ) Medstream Implantable Drug Pump (Model: 91-4200, 91-4201) |
| |
|
| |
[5 May 2010] Philips Heartstart MRx Defibrillator Monitors |
| |
|
| |
[5 May 2010] Baxter Colleague Volumetric Infusion Pump |
| |
|
| |
[5 May 2010] Medtronic Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK), Maximo II DR/VR (D284DRC, D284VRC) |
| |
|
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[21 April 2010] Covidien Shiley tracheostomy products (lot no. in the range of 0810XXXXXX to 0908XXXXXX) |
| |
|
| |
[21 April 2010] Cyberonics VNS Therapy Model 250 Programming Software (version 7.1) for demipulse and demipulse duo generators |
| |
|
| |
[15 April 2010] Animas A) 2020 Insulin Pump, B) OneTouch Ping Insulin Pump (Model : A) 100-380-51, 100-381-51, 100-382-51, 100-384-51, 100-385-51, 200-260-51, 200-261-51, 200-262-51, 200-263-51, 200-264-51, 200-265-51, 200-370-00, 200-371-00, 200-372-00, 200-374-00, 200-375-00, B) 100-420-51, 100-421-51, 100-422-51, 100-424-51, 100-425-51, 100-430-51, 100-431-51, 100-432-51, 100-434-51, 100-435-51) |
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|
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[15 April 2010] Precision Medical Flow Selector (Model : PM1000) |
| |
|
| |
[15 April 2010] Fresenius Medical Care Disinfection block (spare part) for 5008 & 5008S dialysis system |
| |
|
| |
[15 April 2010] Kimal Long Term Haemodialysis Catheters |
| |
|
| |
[13 April 2010] BrainLAB iPlan RT Dose software versions 4.0, 4.1.0 and 4.1.1 (Model No. 21213C, 21213D and 21213E) used with Monte Carlo Dose Algorithm 23071 |
| |
|
| |
[12 April 2010] ArjoHuntleigh Minstrel patient hoist (non scale type) |
| |
|
| |
[9 April 2010] ConMed Electrosurgery Goldline Rocker Switch Pencil (Cat. # 130301A, 130304A, 130307A, 130319A, 130327A, 130337A, 130339A, 131307A, 131319A, 131327A, 60-6829-001A, 60-6829-005A) |
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|
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[31 March 2010] Recall of IMGHC-TX, IMGHC-MX, IMGHC-LS silicone-filled breast implant manufactured by POLY IMPLANT PROTHESE (PIP) |
| |
|
| |
[31 March 2010] GE Healthcare Trusat Oximeter and Trusat Oximeter With Expension Option |
| |
|
| |
[29 March 2010] Lancer Fibro Cleaner Automatic Endoscope Reprocessors FC4 |
| |
|
| |
[29 March 2010] Varian FastPlan Conical Collimator Plans |
| |
|
| |
[29 March 2010] Abbott Diagnostics ARCHITECT Anti-HCV Reagents List numbers: 6C37-20, 6C37-25 and 6C37-30 |
| |
|
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[26 March 2010] Biotest Medical Diagnostics Seraclone Anti-k (KEL2) |
| |
|
| |
[25 March 2010] Centurion Medical Products Pump Fill Kit DT10175 |
| |
|
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[18 March 2010] Arrow International (Teleflex Medical) MAC Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device (Catalog/Part # ASK-21242-UVA2), Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath (Catalog/Part # ASK-29803-SJH), Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-42703-SJH), Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-42802-SHB), Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-45703-SHB), Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-45703-UVA2) |
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[18 March 2010] Medical Action Industries Bundle Kit, using MPS Acacia with Q-Syte BD#385151 (Cat. no. 69946B), Venous Access Tray, using BD Q-Syte Luer Access Split Septum BD #385100 (Cat. no. 69498), Dialysis Kit, using BD Q-Syte Luer Access Split Septum BD #385100 (Cat. no. 57977) |
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|
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[18 March 2010] Gyrus Medical Micron Bobbin Vent Tube T, 1.27 mm, Catalog (REF) Number 145281-ENT, Lot Number MH136952 |
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|
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[17 March 2010] Nova Medical Nova Statstrip Glucose Test Strips (lot no. 0309019249) |
| |
|
| |
[17 March 2010] Unomedical (Convatec) Unilect ECG Electrodes |
| |
|
| |
[16 March 2010] GE Healthcare 1011-9000-000 Aisys Anesthesia Machine and Monitor, 1009-9002-000 Avance Anesthesia Machine and Monitor |
| |
|
| |
[16 March 2010] Teleflex Medical Arrow Select IV Tubing Sets, Accessories, and Certain Embolectomy Catheters |
| |
|
| |
[12 March 2010] Baylis Medical Torflex Transseptal Guiding Sheath (Model no. TF8-38-62-S, Lot no. S21244, S21903, S21940, S22739, and S22739X1) |
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|
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[11 March 2010] Beckman Coulter UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell. UniCel DxC 600 (PN No. A10405), 600 PRO (A11810), 600i (A27318), 800 (A11816), 800 PRO (A11812), 880i (A59102), 680i (A64903), 660i (A64871), 860i (A64935) |
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|
| |
[11 March 2010] Abiomed AB5000 Circulatory Support System (Cat. No. 0015-0000, Serial No. AD5001 through AD5496 except AD5006 & AD5018) |
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|
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[9 March 2010] Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; CardioVive 92531, 92532, 92533; NK 9200G, 9231; Responder 2019198 and 2023440 (9 March 2010) |
| |
|
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[8 March 2010] Thomas Medical Products Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit) |
| |
|
| |
[5 March 2010] Medtronic Physio-Control LIFEPAK 15 |
| |
|
| |
[4 March 2010] Novacare Alternating pressure mattress overlay (ASX) |
| |
|
| |
[1 March 2010] StatSpin (IRIS Sample Processing) StatSpin Express 4 Centrifuges (Model #510) Stryker Instruments Navigation System II CART / PC SPC-1 [18 February 2010] |
| |
|
| |
[18 February 2010] Pointe Scientific Liquid Glucose (HEXO) Reagent Set - 814301, 820502, 823901, 826801, 829401, 814301, 820502, 831502 |
| |
|
| |
[17 February 2010] Philips Healthcare Allura Xper Systems / Allura Integris Systems with Velara Generator |
| |
|
| |
[17 February 2010] Baxter HomeChoice Automated PD System / HomeChoice PRO Automated PD |
| |
|
| |
[10 February 2010] Acacia IV Extension Sets with BD Q-Syte Luer Access Device (REF: 385150, 385151, 385164, 385165, 385166) |
| |
|
| |
[10 February 2010] BD BD Q-Syte Luer Access (Cat no. 380510, 385100, 385101) and BD Nexiva Closed IV Catheter Systems (Cat. No. 383530, 383531, 383532, 383533, 383534, 383536, 383537, 383538, 383539,383540,383647,383649) |
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|
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[9 February 2010] Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning System Version 3.0, 3.1, 3.5.0, 3.5.1) |
| |
|
| |
[9 February 2010] Covidien Moltech/Accutronics Battery (Rev. D & E) used in Legendair and Supportair ventilators and Associated Accessory-Open Pack |
| |
|
| |
[8 February 2010] Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, CardioLife 9200G and 9231 (manufactured/serviced between Oct 19, 2009 and Jan 15, 2010) |
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|
| |
[5 February 2010] Thomas Medical Products Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport |
| |
|
| |
[4 February 2010] Dana Douglas A) Nexus 1, B) Nexus 2 |
| |
|
| |
[4 February 2010] Centurion Healthcare Products (code no. LM110, LM115) |
| |
|
| |
[2 February 2010] Philips Switched Reusable Internal Defibrillation Paddles (Product Numbers M4741A, M4742A, M4743A and M4744A) |
| |
|
| |
[1 February 2010] Inion CPS baby screw (REF: SCR-1221, Lot no. 0809009 and 0809069) |
| |
|
| |
[29 January 2010] Edwards Lifesciences Aquarius Hemodialysis System (Model no. GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04) |
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|
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[27 January 2010] Exelint Exelint Exel/Exelint Huber needles (Code: 26901, 26902, 26904, 26906, 26907, 26908, 26909, 26911, 26921, 26922, 26923, 26924, 26925), Exel/Exelint Huber Infusion Sets (Code: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 27954R, 27955R, 27958R, 27959R) and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets (Code: 37854S, 37855S, 37858S) |
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[25 January 2010] Hettich Plastic Hematocrit Rotors - 201424-01 Haematokrit 20 with 2050 haematocrit rotor, 2004-01 Mikro 20 with 2076 haematocrit rotor, 2070 Mikro 12-24 with 2050 haematocrit rotor, 2075 Haematokrit 24 with 2050 haematocrit rotor - |
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[25 January 2010] Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning System Version 3.5) |
| |
|
| |
[22 January 2010] Philips Heartstart FRx AED (861304) and Heartstart HS1 Onsite Defrillator (M5066A) |
| |
|
| |
[14 January 2010] Merit Medical Systems Mistique Infusion Catheters |
| |
|
| |
[6 January 2010] ev3 Trailblazer Support Catheter (Model no. SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150) |
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| 重要告示
