以 下 的 文 件 是 一 份 關 於 部 份 有 潛 在 危 險 的 醫 療 儀 器 安 全 資 訊 的 摘 要 ， 它 只 可 作 為 快 速 參 考 之 用 ， 並 不 應 被 視 為 完 全 及 最 新 。 詳 情 請 參 閱 有 關 的 資 訊 來 源 及 聯 絡 製 造 商 或 本 地 供 應 商 。 ( 修 訂 於 2010 年 3 月 12 日 )
| Summary for the Current Year |
  |
| Summary for Previous Years |
|
| |
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) (11 March 2010) |
| |
|
| |
Abiomed AB5000 Circulatory Support System (Cat. No. 0015-0000, Serial No. AD5001 through AD5496 except AD5006 & AD5018) (11 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) |
| |
|
| |
Thomas Medical Products Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit) (8 March 2010) |
| |
|
| |
Medtronic Physio-Control LIFEPAK 15 (5 March 2010) |
| |
|
| |
Novacare Alternating pressure mattress overlay (ASX) (4 March 2010) |
| |
|
| |
StatSpin (IRIS Sample Processing) StatSpin Express 4 Centrifuges (Model #510) (1 March 2010) |
| |
|
| |
Stryker Instruments Navigation System II CART / PC SPC-1 (18 February 2010) |
| |
|
| |
Pointe Scientific Liquid Glucose (HEXO) Reagent Set - 814301, 820502, 823901, 826801, 829401, 814301, 820502, 831502 (18 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 (17 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) (10 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 (9 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) (8 February 2010) |
| |
|
| |
Thomas Medical Products Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport (5 February 2010) |
| |
|
| |
Dana Douglas A) Nexus 1, B) Nexus 2 (4 February 2010) |
| |
|
| |
Centurion Healthcare Products (code no. LM110, LM115) (4 February 2010) |
| |
|
| |
Philips Switched Reusable Internal Defibrillation Paddles (Product Numbers M4741A, M4742A, M4743A and M4744A) (2 February 2010) |
| |
|
| |
Inion CPS baby screw (REF: SCR-1221, Lot no. 0809009 and 0809069) (1 February 2010) |
| |
|
| |
Edwards Lifesciences Aquarius Hemodialysis System (Model no. GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04) (29 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) (27 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 - (25 January 2010) |
| |
|
| |
Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning System Version 3.5) (25 January 2010) |
| |
|
| |
Philips Heartstart FRx AED (861304) and Heartstart HS1 Onsite Defrillator (M5066A) (22 January 2010) |
| |
|
| |
Merit Medical Systems Mistique Infusion Catheters (14 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) (6 January 2010) |
| |
|
| |
Biosense Webster (a JNJ company) NaviStar RMT Diagnostic/Ablation Steerable Tip Catheters (22 December 2009) |
| |
|
| |
Biomet Vanguard lock-on femoral impactor 32-486206 (22 December 2009) |
| |
|
| |
Biosense Webster (a JNJ company) Carto 3 System (10 December 2009) |
| |
|
| |
Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs (8 December 2009) |
| |
|
| |
Medtronic Legend AF01 Footed Attachment (8 December 2009) |
| |
|
| |
Immucor Galileo Echo Blood Bank Analyzer (8 December 2009) |
| |
|
| |
STERIS System 1 Processor (SS1) (7 December 2009) |
| |
|
| |
Nipro Europe Pureflux Dialyser (PF-210L) (4 December 2009) |
| |
|
| |
St Jude Medical Epicor Ultrawand LP (4 December 2009) |
| |
|
| |
Fresenius Kabi Agilia Volumat Administration Sets VLON90 (4 December 2009) |
| |
|
| |
Cordis CROSSOVER Sheath Introducer Cat. No. 403545S, 403585S, 403645S, 403685S, 403745S, 403785S (28 November 2009) |
| |
|
| |
Cardiovascular Systems ViperSheath Sheath Introducer (18 November 2009) |
| |
|
| |
Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices (16 November 2009) |
| |
|
| |
Smith & Nephew Endo Femoral Aimers (9 November 2009) |
| |
|
| |
Synthes Ti Synex II Vertebral Body Replacement (VBR) (13 November 2009) |
| |
|
| |
ConMed Linvatec MC5057 Universal Cable (13 November 2009) |
| |
|
| |
ConMed Linvatec PowerPro, PowerProMax and Mpower handpieces (13 November 2009) |
| |
|
| |
Maquet Servo Ventilators Models SV300 and SV900 (13 November 2009) |
| |
|
| |
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter Models EC1001 and EC65 (12 November 2009) |
| |
|
| |
URIT Uritest 13G urine test strips (6 November 2009) |
| |
|
| |
Unomedical Manual Pulmonary Resuscitators (2009 年 10 月 13 日) |
| |
|
| |
飛 利 浦 HeartStart FR2 M3860A/M3861A, M3840A/M3841A 自 動 體 外 去 纖 顫 器 ( 2009 年 9 月 29 日 ) |
| |
|
| |
Medtronic Concerto CRT-D and Virtuoso ICD (2009年9月9日) |
| |
|
| |
Welch Allyn AED 10 and MRL JumpStart Defibrillators (2009年7月21日) |
| |
|
| |
Boston Scientific LeVeen Needle Electrodes - 5.0cm (2009年7月10日) |
| |
|
| |
Medtronic QUICK-SET INFUSION SETS Models MMT-396, MMT-397, MMT-398 and MMT-399 (2009 年 7 月 10 日) |
| |
|
| |
Medtronic Model 8551 SynchroMed Refill Kits w/ reversed UBD and Mfg Dates (2009 年 7 月 10 日) |
| |
|
| |
Boston Scientific Flexima and Percuflex drainage catheter family (pigtail style, peripheral interventions), Percuflex and percutaneous model drainage catheter family (urology) (2009 年 7 月 10 日) |
| |
|
| |
BD 60ml Lurt-Lok Syringes (Recorder Number 309653; Lot No.: 819101A) ( 2009 年 7 月 9 日 ) |
| |
|
| |
Respironics BiPAP Focus Noninvasive Ventilator System ( 2009 年 7 月 9 日 ) |
| |
|
| |
Boston Scientific Flexima Biliary Catheter System ( 2009 年 7 月 8 日 ) |
| |
|
| |
Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump Battery Performance ( 2009 年 7 月 6 日 ) |
| |
|
| |
Bausch & Lomb Boston Conditioning Solution Original Formula ( 2009 年 7 月 2 日 ) |
| |
|
|
| 重要告示
