Field Safety Notices
Field Safety Notice - Sep 2019
Audiences
Healthcare professional
Industry member
Product type
Medical devices
30 September 2019
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
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) | |
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] |
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] |
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 | |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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 | |
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] |
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] |
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] |
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] |
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 | |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
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] |
4 Sep 2019 | Euphora™ Semi-Compliant Rapid Exchange Balloon Dilatation Catheters, Medtronic Inc (HSA 600:41/01-009/19/12_56) | |
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] |
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] |
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 | |
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] |
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] |
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] |
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] 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] This FSN is an update to the original FSN published in July 2019. |