Field Safety Notices
Field Safety Notice - Nov 2019
30 November 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Nov 2019 | GSP Neonatal IRT Kit, Wallac Oy (HSA 600:41/01-127/19/01_78) | HSA 6004101-127-19-01_78 FSN [PDF, 3481 KB] (opens in new tab) |
29 Nov 2019 | BD FACSLyric Flow Cytometer, Becton, Dickinson and Company (HSA 600:41/01-003/19/16_57) | HSA 6004101-003-19-16_57 FSN [PDF, 105 KB] (opens in new tab) |
28 Nov 2019 | Architect Reaction Vessels, Abbott Laboratories (HSA 600:41/01-005/19/33_73) | HSA 6004101-005-19-33_73 FSN [PDF, 201 KB] (opens in new tab) |
28 Nov 2019 | Philips Prodiva 1.5T CS/CX MRI Systems, Philips Healthcare (Suzhou) Co. Ltd (HSA 600:41/01-026/19/38_74) | HSA 6004101-026-19-38_74 FSN [PDF, 132 KB] (opens in new tab) |
28 Nov 201 | COOK CrossCath Support Catheter, Cook Incorporated (HSA 600:41/01-013/19/12_79) | HSA 6004101-013_19_12_79 FSN [PDF, 67 KB] (opens in new tab) |
27 Nov 2019 | Pin to Rod Coupling Hoffmann II Compact 5/3-4mm, Stryker GmbH (HSA 600:41/01-014/19/09_18) | HSA 6004101-014-19- 09_18 FSN [PDF, 224 KB] (opens in new tab) |
27 Nov 2019 | UNISEPTA FOAM 2, USF Healthcare (HSA 600:41/01-335/19/03_50) | HSA 6004101-335-19-03_50 FSN [PDF, 266 KB] (opens in new tab) |
26 Nov 2019 | bellavista 1000 ventilator, bellavista 1000 NEO ventilator, bellavista 1000e 17,3" ventilator, bellavista 1000 Set ventilator, IMT Medical AG (HSA 600:41/01-199/19/04_44) Local Contact: Junnimed Services Pte Ltd | HSA 6004101-199-19-04_44 FSN [PDF, 1924 KB] (opens in new tab) |
25 Nov 2019 | Cios Alpha System, Siemens Healthcare GmbH (HSA 600:41/01-022/19/28_71) | HSA 6004101-022-19-28_71 FSN [PDF, 888 KB] (opens in new tab) |
25 Nov 2019 | WEINMANN MEDUCORE STANDARD2 Monitor / Defibrillator WM 45300, WEINMANN Emergency Medical Technology GmbH + Co. KG (HSA 600:41/01-301/19/03_64) | HSA 6004101-301-19-03_64 FSN [PDF, 207 KB] (opens in new tab) |
24 Nov 2019 | Bard Site~Rite 8 Ultrasound System, Bard Access Systems Inc (HSA 600:41/01-003/19/15_46) | HSA 6004101-003-19-15_46 FSN [PDF, 130 KB] (opens in new tab) |
22 Nov 2019 | Syramed μSP6000 and Volumed μVP7000, Acromed AG (HSA 600:41/01-113/19/02_37) Local Contact: Equip Medical Pte Ltd | HSA 6004101-113-19-02_37 FSN [PDF, 179 KB] (opens in new tab) |
22 Nov 2019 | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator and Atellica CH High Sensitivity C-Reactive Protein (hsCRP) Calibrator, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/27_75) | HSA 6004101-022-19-27_75 FSN [PDF, 264 KB] (opens in new tab) |
21 Nov 2019 | Cordis S.M.A.R.T. and PRECISE Stents, Cordis Corporation (HSA 600:41/01-307/19/03_35) Local Contact: Cardinal Health Singapore 225 Pte Ltd. | HSA 6004101-307-19-03_35 FSN [PDF, 220 KB] (opens in new tab) |
19 Nov 2019 | SURFA'SAFE PREMIUM, Laboratoires Anios (HSA 600:41/01-017/19/03_48) Local Contact: IDS Medical Systems (Singapore) Pte Ltd | HSA 6004101-017-19-03_48 FSN [PDF, 63 KB] (opens in new tab) |
18 Nov 2019 | HISCL FT-4 Reagent, Sysmex Corporation (HSA 600:41/01-032/19/05_61) | HSA 6004101-032-19-05_61 FSN [PDF, 406 KB] (opens in new tab) |
15 Nov 2019 | Closed Suction System for Neonates/Pediatrics (5Fr), Avanos Medical, Inc. (HSA 600:41/01-352/19/01_46) | HSA 6004101-352-19-01_46 FSN [PDF, 330 KB] (opens in new tab) |
15 Nov 2019 | Gambro Prismaflex Haemodialysis Control Unit, Gambro Lundia AB (HSA 600:41/01-001/19/07_18) Local Contact: Baxter Healthcare (Asia) Pte Ltd | HSA 6004101-001-19-07_18 FSN [PDF, 535 KB] (opens in new tab) |
14 Nov 2019 | STA - UNICALIBRATOR, UNICALIBRATOR, SYSTEM CONTROL N + P, STA - SYSTEM CONTROL N + P, STA - Quali-Clot 1, STA - Quali-Clot II, DIAGNOSTICA STAGO (HSA 600:41/01-137/19/01_89) | HSA 6004101-137-19-01_89 FSN [PDF, 417 KB] (opens in new tab) |
14 Nov 2019 | Minimed 600 Series Insulin Pump, Medtronic Minimed (HSA 600:41/01-009/19/16_68) | HSA 6004101-009-19-16_68 FSN [PDF, 203 KB] (opens in new tab) |
14 Nov 2019 | ARCHITECT CRP Vario and Alinity c CRP Vario Reagent Kit, SENTINEL CH SpA (HSA 600:41/01-005/19/32_31) | HSA 6004101-005-19-32_31 FSN [PDF, 99 KB] (opens in new tab) |
14 Nov 2019 | Mitek HEALIX ADVANCE™, HEALIX ADVANCE™ Knotless, MILAGRO® ADVANCE, and INTRAFIX™ Advance, DePuy Mitek (HSA 600:41/01-002/19/17_82) | HSA 6004101-002-19-17_82 FSN [PDF, 252 KB] (opens in new tab) |
14 Nov 2019 | TruWave Disposable Pressure Transducer System, Edwards Lifesciences LLC (HSA 600:41/01-060/19/10_56) | HSA 6004101-060-19-10_56 FSN [PDF, 310 KB] (opens in new tab) |
14 Nov 2019 | LIGAMAX – 5mm Endoscopic Multiple Clip Applier, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/19/18_88) | HSA 6004101-002-19-18_88 FSN [PDF, 257 KB] (opens in new tab) |
14 Nov 2019 | Artis Zee Systems with VC21C, Siemens Healthcare GmbH (HSA 600:41/01-022/19/26_50) | HSA 6004101-022-19-26_50 FSN [PDF, 790 KB] (opens in new tab) |
12 Nov 2019 | Remel E. coli Polyvalent and Monovalent Agglutinating Sera, Remel Europe Ltd (HSA 600:41/01-178/19/08_59) | HSA 6004101-178-19-08_59 FSN [PDF, 145 KB] (opens in new tab) |
11 Nov 2019 | AngioJet™ Ultra Consoles, Boston Scientific Corporation (HSA 600:41/01-007/19/11_51) | HSA 6004101-007-19-11_51 FSN [PDF, 348 KB] (opens in new tab) |
8 Nov 2019 | ABL90 FLEX and ABL90FLEX Plus, Radiometer Medical ApS (HSA 600:41/01-219/19/01_67) | HSA 6004101-219-19-01_67 FSN [PDF, 247 KB] (opens in new tab) |
8 Nov 2019 | TherMax, Blood Warmer Unit, ROW, Baxter Healthcare SA (HSA 600:41/01-001/19/06_87) | HSA 6004101-001-19-06_87 FSN [PDF, 75 KB] (opens in new tab) |
8 Nov 2019 | Thromborel S, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/19/04_69) | HSA 6004101-032-19-04_69 FSN [PDF, 1185 KB] (opens in new tab) |
7 Nov 2019 | Accu-Chek Performa Blood Glucose Meters, Roche Diabetes Care GmbH (HSA 600:41/01-016/19/27_69) | HSA 6004101-016-19-27_69 FSN [PDF, 2487 KB] (opens in new tab) |
7 Nov 2019 | HemoSphere Advanced Monitor, Edwards Lifesciences LLC (HSA 600:41/01-060/19/09_85) | HSA 6004101-060-19-09_85 FSN [PDF, 117 KB] (opens in new tab) |
6 Nov 2019 | Stryker Colour Cuff Disposable Tourniquet Cuff, Stryker Instruments (HSA 600:41/01-014/19/08_86) | HSA 6004101-014-19-08_86 FSN [PDF, 371 KB] (opens in new tab) |
5 Nov 2019 | IH-QC1, DiaMed GmbH (HSA 600:41/01-027/19/12_78) | HSA 6004101-027-19-12_78 FSN [PDF, 1714 KB] (opens in new tab) |
5 Nov 2019 | STAR Total Ankle Replacement Non-Foil Packed Mobile Bearing Components, Stryker GmbH (HSA 600:41/01-226/19/01_88) | HSA 6004101-226-19-01_88 FSN [PDF, 381 KB] (opens in new tab) |
5 Nov 2019 | ELECSYS TROPONIN T HS & ELECSYS TROPONIN T HS STAT, Roche Diagnostics GmbH (HSA 600:41/01-016/19/26_34) | HSA 6004101-016-19-26_34 FSN [PDF, 437 KB] (opens in new tab) |
5 Nov 2019 | iChemVELOCITY Urine Chemistry System, Beckman Coulter Ireland Inc (HSA 600:41/01-052/19/07_61) | HSA 6004101-052-19-07_61 FSN [PDF, 122 KB] (opens in new tab) |
5 Nov 2019 | Torcon NB® Advantage Catheter, Cook Medical Incorporated and William Cook Europe Aps (HSA 600:41/01-013/19/11_80) | HSA 6004101-013-19-11_80 FSN [PDF, 101 KB] (opens in new tab) |
4 Nov 2019 | DENALI Polyaxial Screw – 6.5 x 45 mm, K2M, Inc. (HSA 600:41/01-322/19/02_62) | HSA 6004101-322-19-02_62 FSN [PDF, 124 KB] (opens in new tab) |
4 Nov 2019 | iQ200 Series Urine Microscopy Analyzer and iChemVELOCITY Urine Chemistry System, Beckman Coulter Ireland Inc (HSA 600:41/01-052/19/06_78) | HSA 6004101-052-19-06_78 FSN [PDF, 89 KB] (opens in new tab) |
4 Nov 2019 | INTOUCH Critical Care Bed, Stryker Medical (HSA 600:41/01-014/19/07_64) | HSA 6004101-014-19-07_64 FSN [PDF, 345 KB] (opens in new tab) |
4 Nov 2019 | QUADROX-iD Pediatric with BIOLINE Coating, Macquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/16_43) Local Contact: Getinge South East Asia Pte Ltd | HSA 6004101-224-19-16_43 FSN [PDF, 417 KB] (opens in new tab) |