Field Safety Notices
Field Safety Notice - Sep 2019
30 September 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
27 Sep 2019 | Nasal Alar SpO2 Sensor, Xhale Assurance Inc (HSA 600:41/01-026/19/33_64) | HSA 6004101-026-19-33_64 FSN [PDF, 131 KB] (opens in new tab) |
27 Sep 2019 | Carescape B850 monitors of version MBC303, GE Healthcare Finland Oy (HSA 600:41/01-010/19/25_37) | HSA 6004101-010-19-25_37 FSN [PDF, 238 KB] (opens in new tab) |
26 Sep 2019 | Elekta Mosaiq, Elekta Inc (HSA 600:41/01-101/19/02_79) | HSA 6004101-101-19-02_79 FSN [PDF, 117 KB] (opens in new tab) |
26 Sep 2019 | Prismaflex M100 and TPE2000 sets, Oxiris set, MARS Treatment Kit type 1116/1 X-MARS, Gambro Lamdia AB (HSA 600:41/01-001/19/03_37) Local Contact: Baxter Healthcare (Asia) Pte Ltd | HSA 6004101-001-19-03_37 FSN [PDF, 376 KB] (opens in new tab) |
24 Sep 2019 | Atellica® CH 930 Analyzer, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/24_75) | HSA 6004101-022-19-24_75 FSN [PDF, 139 KB] (opens in new tab) |
24 Sep 2019 | Implantable Ports & GROSHONG® Central Venous Catheter, BARD Access Systems Inc. (HSA 600:41/01-050/19/04_64) | HSA 6004101-050-19-04_64 FSN [PDF, 606 KB] (opens in new tab) |
23 Sep 2019 | HCYS (Homocysteine Enzymatic Assay), Roche Diagnostics GmbH (HSA 600:41/01-016/19/21_67) | HSA 6004101-016-19-21_67 FSN [PDF, 26 KB] (opens in new tab) |
23 Sep 2019 | DC-Screening II, DiaMed GmbH (HSA 600:41/01-027/19/09_49) | HSA 6004101-027-19-09_49 FSN [PDF, 1811 KB] (opens in new tab) |
23 Sep 2019 | Olympus DuodenoVideoscope, Olympus DuodenoFiberscope, Olympus Medical Systems Corp. (HSA 600:41/01-004/19/05_48) | HSA 6004101-004-19-05_48 FSN [PDF, 254 KB] (opens in new tab) |
23 Sep 2019 | ThermoScientific Oxoid Violet Red Bile Glucose Agar (ISO), Oxoid Limited (HSA 600:41/01-178/19/06_57) | HSA 6004101-178-19-06_57 FSN [PDF, 230 KB] (opens in new tab) |
20 Sep 2019 | Philips V60 Ventilators, Respironics California LLC (HSA 600:41/01-026/19/31_51) | HSA 6004101-026-19-31_51 FSN [PDF, 492 KB] (opens in new tab) |
20 Sep 2019 | PHILIPS V60/V680 VENTILATOR Touchscreen RP Kit, Respironics California LLC (HSA 600:41/01-026/19/32_44) | HSA 6004101-026-19-32_44 FSN [PDF, 410 KB] (opens in new tab) |
20 Sep 2019 | O-Wrap, Tissue-Vault, and CryoStore Accessories, ORIGEN BIOMEDICAL INC. (HSA 600:41/01-348/19/01_35) Local Contact: Essential Resource Marketing | HSA 6004101-348-19-01_35 FSN [PDF, 120 KB] (opens in new tab) |
20 Sep 2019 | Philips V680 Ventilator, Respironics California LLC (HSA 600:41/01-026/19/30_77) | HSA 6004101-026-19-30_77 FSN [PDF, 424 KB] (opens in new tab) |
20 Sep 2019 | iLab™ Polaris Systems (Polaris 2.10), Boston Scientific Corporation (HSA 600:41/01-007/19/08_35) | HSA 6004101-007-19-08_35 FSN [PDF, 173 KB] (opens in new tab) |
19 Sep 2019 | Alinity i Processing Module; Alinity c Processing Module; Alinity ci Level Sensor, Abbott GmbH & Co KG (HSA 600:41/01-005/19/29_31) | HSA 6004101-005-19-29_31 FSN [PDF, 763 KB] (opens in new tab) |
19 Sep 2019 | EV1000 Clinical Platform NI, Edwards Lifesciences LLC (HSA 600:41/01-060/19/06_66) | HSA 6004101-060-19-06_66 FSN [PDF, 204 KB] (opens in new tab) |
17 Sep 2019 | KIT CONSTITUENT SUBSTRATE BUFFER (SUB-D) of four GenoType Mycobacterium Kits (GenoType MTBDRplus, GenoType Mycobacterium CM, GenoType MTBDRsl, GenoType Mycobacterium AS), Hain Lifescience (HSA 600:41/01-086/19/01_57) Local Contact: SPD Scientific Pte Ltd | HSA 6004101-086-19-01_57 FSN [PDF, 1151 KB] (opens in new tab) |
17 Sep 2019 | Respironics V60 Ventilator, RespironIcs California LLC (HSA 600:41/01-026/19/29_66) | HSA 6004101-026-19-29_66 FSN [PDF, 2247 KB] (opens in new tab) |
17 Sep 2019 | GE ApexPro Telemetry System, GE Medical Systems Information Technologies, Inc (HSA 600:41/01-010/19/24_38) | HSA 6004101-010-19-24_38 FSN [PDF, 264 KB] (opens in new tab) |
17 Sep 2019 | Heater Unit HU 35, Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/12_37) | HSA 6004101-224-19-12_37 FSN [PDF, 563 KB] (opens in new tab) |
16 Sep 2019 | Virotrol HIV-2 Control, Bio-Rad Laboratories (HSA 600:41/01-027/19/08_31) | HSA 6004101-027-19-08_31 FSN [PDF, 46 KB] (opens in new tab) |
16 Sep 2019 | BD Emerald™ Syringe, Becton Dickinson India (P) Ltd(HSA 600:41/01-003/19/13_38) | HSA 6004101-003-19-13_38 FSN [PDF, 64 KB] (opens in new tab) |
13 Sep 2019 | Venous Hardshell Cardiotomy Reservoir (VHK 70000/71000) and combination of reservoir with oxygenator (VKMO, VKMOD), Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/10_71) | HSA 6004101-224-19-10_71 FSN [PDF, 3514 KB] (opens in new tab) |
13 Sep 2019 | Disposable CO2 Absorbers, Maquet Critical Care AB (HSA 600:41/01-224/19/11_48) | HSA 6004101-224-19-11_48 FSN [PDF, 1933 KB] (opens in new tab) |
13 Sep 2019 | Various Legacy Biomet Products, Biomet Orthopedics (HSA 600:41/01-008/19/07_18) | HSA 6004101-008-19-07_18 FSN [PDF, 771 KB] (opens in new tab) |
12 Sep 2019 | Atellica IM anti-CCP IgG (aCCP) Assay, Atellica IM Pregnancy-Associated Plasma Protein-A (PAPP-A) Assay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/23_69) | HSA 6004101-022-19-23_69 FSN [PDF, 191 KB] (opens in new tab) |
12 Sep 2019 | Alinity hq Analyser and Alinity hs Slide Marker Stainer Module, Abbott GmbH & Co. Kg (HSA 600:41/01-005/19/28_59) | HSA 6004101-005-19-28_59 FSN [PDF, 273 KB] (opens in new tab) |
11 Sep 2019 | Ortho-Clinical VITROS Chemistry Products Cl- (Chloride) & K+ Slides (Potassium), Ortho-Clinical Diagnostic (HSA 600:41/01-303/19/07_34) | HSA 6004101-303-19-07_34 FSN [PDF, 164 KB] (opens in new tab) |
11 Sep 2019 | MESA Rail Cutter, K2M, Inc. (HSA 600:41/01-322/19/01_56) | HSA 6004101-322-19-01_56 FSN [PDF, 192 KB] (opens in new tab) |
9 Sep 2019 | 1-DAY ACUVUE® MOIST® for ASTIGMATISM Brand Contact Lenses, Johnson & Johnson Vision Inc. (HSA 600:41/01-140/19/01_74) | HSA 6004101-140-19-01_74 FSN [PDF, 519 KB] (opens in new tab) |
6 Sep 2019 | DiaMed IH-1000, DiaMed GmbH (HSA 600:41/01-027/19/07_23) | HSA 6004101-027-19-07_23 FSN [PDF, 5373 KB] (opens in new tab) |
6 Sep 2019 | Achilles Express and Achilles Insights Systems, GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC (HSA 600:41/01-010/19/23_52) | HSA 6004101-010-19-23_52 FSN [PDF, 314 KB] (opens in new tab) |
4 Sep 2019 | STRATAFIX™ Spiral PDS Plus Knotless Tissue Control Device, Ethicon, LLC (HSA 600:41/01-002/19/15_51) | HSA 6004101-002-19-15_51 FSN [PDF, 316 KB] (opens in new tab) |
4 Sep 2019 | Euphora™ Semi-Compliant Rapid Exchange Balloon Dilatation Catheters, Medtronic Inc (HSA 600:41/01-009/19/12_56) | HSA 6004101-009-19-12_56 FSN [PDF, 159 KB] (opens in new tab) |
4 Sep 2019 | Philips Access Computed Tomography X-ray system, Philips Healthcare (Suzhou) CO. Ltd (HSA 600:41/01-026/19/28_79) | HSA 6004101-026-19-28_79 FSN [PDF, 9963 KB] (opens in new tab) |
3 Sep 2019 | Convex Two-Piece Skin Barriers i.e. Natura / Surfit / Combihesive Wafers, ConvaTec Limited (HSA 600:41/01-347/19/01_87) | HSA 6004101-347-19-01_87 FSN [PDF, 940 KB] (opens in new tab) |
3 Sep 2019 | Introcan Safety Pur 24G, 0.7X19MM-AP, B.Braun Melsungen AG (HSA 600:41/01-012/19/04_85) Local Contact: B. Braun Singapore Pte Ltd | HSA 6004101-012-19-04_85_FSN [PDF, 2826 KB] (opens in new tab) |
2 Sep 2019 | Triathlon Total Knee Replacement System, Howmedica Osteonics Corporation (HSA 600:41/01-014/19/04_74) | HSA 6004101-014-19-04_74 FSN [PDF, 152 KB] (opens in new tab) |
2 Sep 2019 | ALB2 (Albumin Gen.2) and BILT3 (Bilirubin Total Gen.3), Roche Diagnostics GmbH (HSA 600:41/01-016/19/19_61) | HSA 6004101-016-19-19_61 FSN [PDF, 401 KB] (opens in new tab) |
2 Sep 2019 | IgG-2 Tina-quant IgG Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/19/20_61) | HSA 6004101-016-19-20_61 FSN [PDF, 21 KB] (opens in new tab) |
26 July 2019 | BD MAX™ Reagents, Becton Dickinson and Company (HSA 600:41/01-003/19/08_73) | HSA 6004101-003-19-08_73 FSN [PDF, 205 KB] (opens in new tab) This FSN is an update to the original FSN published in July 2019. |
8 July 2019 | ICS Chartr EP 200, GN Otometrics A/S (HSA 600:41/01-104/19/01_68) | HSA 6004101-104-19-01_68 FSN [PDF, 202 KB] (opens in new tab) This FSN is an update to the original FSN published in July 2019. |