Field Safety Notices
Field Safety Notice - May 2019
31 May 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 May 2019 | ARCHITECT BNP Calibrators/Controls, Abbott GmbH and Co KG (HSA 600:41/01-005/19/22_75) | HSA 6004101-005-19-22_75 FSN [PDF, 387 KB] (opens in new tab) |
30 May 2019 | Abbott Hemoglobin A1c Calibrators, Abbott Laboratories (HSA 600:41/01-005/19/21_57) | HSA 6004101-005-19-21_57_FSN [PDF, 290 KB] (opens in new tab) |
30 May 2019 | Healing Abutment Conical Connection RP Ǿ3.6 x 5 mm, Nobel Biocare AB (HSA 600:41/01-168/19/01_71) | HSA 6004101-168-19-01_71 FSN [PDF, 57 KB] (opens in new tab) |
29 May 2019 | Sheridan® Endotracheal Tubes and Connectors, Teleflex Medical (HSA 600:41/01-139/19/02_18) | HSA 6004101-139-19-02_18 FSN [PDF, 153 KB] (opens in new tab) |
29 May 2019 | Senographe Pristina with Serena, GE Medical Systems SCS (HSA 600:41/01-010/19/15_56) | HSA 6004101-010-19-15_56 FSN [PDF, 275 KB] (opens in new tab) |
29 May 2019 | DVR® Crosslock ePAK™ Screw Driver, DVR® Crosslock ePAK™ Depth Gauge, K-Wire Trochar Tip, Biomet Trauma (HSA 600:41/01-008/19/03_79) | HSA 6004101-008-19-03_79 FSN [PDF, 263 KB] (opens in new tab) |
28 May 2019 | Tina‑quant IgA Gen.2 on cobas c 701/702, Roche Diagnostics GmbH (HSA 600:41/01-016/19/09_73) | HSA 6004101-016-19-09_73 FSN [PDF, 36 KB] (opens in new tab) |
28 May 2019 | AssayTip/ AssayCup, Roche Diagnostics GmbH (HSA 600:41/01-016/19/08_34) | HSA 6004101-016-19-08_34 FSN [PDF, 153 KB] (opens in new tab) |
27 May 2019 | ARTIS zee and AXIOM Artis systems with Generator A100, Siemens Healthcare GmbH (HSA 600:41/01-022/19/11_46) | HSA 6004101-022-19-11_46 FSN [PDF, 771 KB] (opens in new tab) |
27 May 2019 | Incisive Computed Tomography X-ray System, Philips Healthcare (Suzhou) Co. Ltd. (HSA 600:41/01-026/19/16_74) | HSA 6004101-026_19-16_74_FSN [PDF, 1344 KB] (opens in new tab) |
27 May 2019 | Lactate Gen.2 (Cobas Integra 400 Plus), Roche Diagnostics GmbH (HSA 600:41/01-016/19/07_67) | HSA 6004101-016-19-07_67 FSN [PDF, 377 KB] (opens in new tab) |
27 May 2019 | HeartStart MRx Defibrillator/ Monitor, Philips Medical Systems (HSA 600:41/01-026/19/15_68) | HSA 6004101-026-19-15_68 FSN [PDF, 450 KB] (opens in new tab) |
27 May 2019 | Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter, Cook Incorporated (HSA 600:41/01-013/19/07_68) | HSA 6004101-013-19-07_68 FSN [PDF, 75 KB] (opens in new tab) |
27 May 2019 | iQ Control/Focus Set, Iris Diagnostics (HSA 600:41/01-052/19/03_70) | HSA 6004101-052-19-03_70 FSN [PDF, 230 KB] (opens in new tab) |
24 May 2019 | Alinity c Complement C3 Reagent Kit, Alinity c Immunoglobulin A Reagent Kit, Alinity c Immunoglobulin G Reagent Kit, Alinity c Immunoglobulin M Reagent Kit, Alinity c Apolipoprotein A1 Reagent Kit, Alinity c Complement C4 Reagent Kit, Alinity c Haptoglobin Reagent Kit, Alinity c Apolipoprotein B Reagent Kit, Alnity c Transferrin Reagent Kit, Abbott GmbH & Co KG (HSA 600:41/01-005/19/20_57) | HSA 6004101-005-19-20_57 FSN [PDF, 241 KB] (opens in new tab) |
24 May 2019 | Coloplast Biatain Ibu Non-Adhesive Foam Dressing & Coloplast Biatain Ag Foam Dressing, Coloplast A/S (HSA 600:41/01-341/19/01_18) | HSA 6004101-341-19-01_18 FSN [PDF, 402 KB] (opens in new tab) |
24 May 2019 | Covidien Endo GIA™ articulating reloads with Tri-Staple™ technology, Covidien llc (HSA 600:41/01-046/19/07_52) | HSA 6004101-046-19-07_52 FSN [PDF, 343 KB] (opens in new tab) |
24 May 2019 | ARCHITECT Complement C3, ARCHITECT Immunoglobulin A, ARCHITECT Immunoglobulin G, ARCHITECT Immunoglobulin M, ARCHITECT Apolipoprotein A1, ARCHITECT Complement C4, ARCHITECT Haptoglobin, ARCHITECT Apolipoprotein B, ARCHITECT Transferrin, Abbott Laboratories (HSA 600:41/01-005/19/19_23) | HSA 6004101-005-19-19_23 FSN [PDF, 318 KB] (opens in new tab) |
24 May 2019 | Alinity ci-series System Control Module, Abbott GmbH & Co KG (HSA 600:41/01-005/19/18_59) | HSA 6004101-005-19-18_59 FSN [PDF, 384 KB] (opens in new tab) |
23 May 2019 | ID-DIACELL I-II-III ASIA, Diamed GmbH (HSA 600:41/01-027/19/03_67) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd | HSA 6004101-027-19-03_67 FSN [PDF, 1782 KB] (opens in new tab) |
23 May 2019 | Prismaflex System, Prismaflex 4.11, Prismaflex 6.10 ROW and Prismaflex 8.XX ROW (8.10 software), Gambro Lundia AB (HSA 600:41/01-001/19/02_56) Local Contact: Baxter Healthcare (Asia) Pte Ltd | HSA 6004101-001-19-02_56 FSN [PDF, 2798 KB] (opens in new tab) |
22 May 2019 | O-arm™ 1000 Imaging System, Medtronic Inc (HSA 600:41/01‐009/19/08_86) Local Contact: Medtronic International Ltd. | HSA 6004101‐009-09-08_86 FSN [PDF, 919 KB] (opens in new tab) |
22 May 2019 | Medtronic Guardian™ Connect CGM System, Medtronic MiniMed (HSA 600:41/01-009/19/09_51) Local Contact: Medtronic International Ltd. | HSA 6004101-009-19-09_51 FSN [PDF, 495 KB] (opens in new tab) |
22 May 2019 | ETHIBOND EXCEL Polyester Nonabsorbable Surgical Suture, Ethicon LLC and Ethicon, Inc. (HSA 600:41/01-002/19/14_46) | HSA 6004101-002-19-14_46 FSN_Redacted [PDF, 246 KB] (opens in new tab) |
21 May 2019 | Discovery PET/CT 610, 710; Optima PET/CT 560, 560FX; Discovery IQ; Discovery MI, MI DR; GE Medical Systems, LLC (HSA 600:41/01-010/19/14_80) | HSA 6004101-010-19-14_80 FSN_Redacted [PDF, 99 KB] (opens in new tab) |
21 May 2019 | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only), 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0), Mako Surgical Corp (HSA 600:41/01-070/19/05_50) | HSA 6004101-070-19-05_50 FSN [PDF, 146 KB] (opens in new tab) |
17 May 2019 | QUADROX-i Neonatal, Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/05_86) | HSA 6004101-224-19-05_86 FSN_Redacted [PDF, 333 KB] (opens in new tab) |
16 May 2019 | WEINMANN Emergency Medical Technology MEDUCORE Standard Monitor/Defibrillator, WEINMANN Emergency Medical Technology GmBh + Co.KG (HSA 600:41/01-056/19/03_80) | HSA 6004101-056-19-03_80 FSN [PDF, 181 KB] (opens in new tab) |
16 May 2019 | CELL-DYN Emerald and Emerald Diluent Tubing, Abbott Laboratories (HSA 600:41/01-005/19/17_23) | HSA 6004101-005-19-17_23 FSN_Redacted [PDF, 291 KB] (opens in new tab) |
15 May 2019 | Vscan Extend, GE Vingmed Ultrasound AS (HSA 600:41/01-010/19/13_52) | HSA 6004101-010-19-13_52 FSN_Redacted [PDF, 158 KB] (opens in new tab) |
15 May 2019 | Cook Neff Percutaneous Access Sets, Cook Incorporated (HSA 600:41/01-013/19/06_64) | HSA 6004101-013-19-06_64 FSN_Redacted [PDF, 73 KB] (opens in new tab) |
15 May 2019 | Cook Zenith Alpha Abdominal Endovascular Graft, William Cook Europe Aps(HSA 600:41/01-013/19/05_62)Local Contact: Cook South East Asia Pte Ltd | HSA 6004101-013-19-05_62 FSN_Redacted [PDF, 1424 KB] (opens in new tab) |
15 May 2019 | Renasys-F Foam Dressing Kit, Smith & Nephew Medical Ltd (HSA 600:41/01-073/19/08_48) | HSA 6004101-073-19-08_48 FSN [PDF, 100 KB] (opens in new tab) |
14 May 2019 | Feeding Tubes, Nelaton Catheters, Levin Tubes, Rectal Catheter, Ryles Tube, Suction Catheters, Stomach Tubes, Medical Packs, Pennine Healthcare (HSA 600:41/01-044/19/02_50) | HSA 6004101-044-19-02_50 FSN_Redacted [PDF, 490 KB] (opens in new tab) |
13 May 2019 | Covidien Emprint Ablation Pumps, Remote Temperature Probes, Reusable Cables and Generators, Covidien llc (HSA 600:41/01-046/19/06_76) | HSA 6004101-046-19-06_76 FSN_Redacted [PDF, 1025 KB] (opens in new tab) |
13 May 2019 | D-Special Product Codes of PROLENE® Polypropylene Non-Absorbable Suture and PRONOVA® Poly (Hexafluoropropylene - VDF) Suture, Ethicon LLC and Ethicon, Inc. (HSA 600:41/01-002/19/13_44) | HSA 6004101-002-19-13_44 FSN_Redacted [PDF, 205 KB] (opens in new tab) |
10 May 2019 | Medtronic HeartWare™ Monitor AC Adapter, HeartWare (HSA 600:41/01-263/19/02_63) | HSA 6004101-263-19-02_63 FSN_Redacted [PDF, 256 KB] (opens in new tab) |
9 May 2019 | ARCHITECT c Systems Mixer, Abbott Laboratories (HSA 600:41/01-005/19/16_61) | HSA 6004101-005-19-16_61 FSN [PDF, 476 KB] (opens in new tab) |
8 May 2019 | Membrane Changerand their Inserts of Sentec Digital Monitoring System, SenTec Ag (HSA 600:41/01-199/19/03_43) | HSA 6004101-199-19-03_43 FSN_Redacted [PDF, 210 KB] (opens in new tab) |
8 May 2019 | VICRYL™ Plus Absorbable Surgical Suture, and ETHIBOND Excel Polyester Suture, Ethicon LLC (HSA 600:41/01-002/19/12_51) | HSA 6004101-002-19-12_51 FSN_Redacted [PDF, 284 KB] (opens in new tab) |
8 May 2019 | CORAIL® Cementless Stem, DePuy (Ireland) (HSA 600:41/01-002/19/11_54) | HSA 6004101-002-19-11_54 FSN_Redacted [PDF, 185 KB] (opens in new tab) |
7 May 2019 | BILT3 COBAS C 111, BILT3 COBAS INTEGRA® 400 PLUS, Roche Diagnostics GmbH (HSA 600:41/01-016/19/06_78) | HSA 6004101-016-19-06_78 FSN [PDF, 402 KB] (opens in new tab) |
7 May 2019 | Medtronic Azure™ MRI SureScan™ Pacemaker, Medtronic Astra™ MRI SureScan™ Pacemaker, Medtronic Percepta™ CRT-P MRI SureScan™, Medtronic Serena™ CRT-P MRI SureScan™, Medtronic Solara™ CRT-P MRI SureScan™, Medtronic Inc (HSA 600:41/01-009/19/07_71) | HSA 6004101-009-19-07_71 FSN_Redacted [PDF, 135 KB] (opens in new tab) |
6 May 2019 | Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) Flowmeter, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/19/03_79) | HSA 6004101-028-19-03_79 FSN_Redacted [PDF, 3059 KB] (opens in new tab) |
6 May 2019 | Access Free T3, Access Total T3, Access Free T4, Access GI Monitor (GI Mon), Access Thyroglobulin (Tg), Access Thyroglobulin Antibody II (TgAbII), Beckman Coulter Inc (HSA 600:41/01-052/19/02_73) | HSA 6004101-052-19-02_73 FSN_Redacted [PDF, 119 KB] (opens in new tab) |
6 May 2019 | Prestige II, Prestige VH, Prestige SI, Prestilix 1600X, Precision 500D, Flexmed, PROTEUS XR/A and SILHOUETTE VR, GE Hualun Medical Systems Co Ltd (HSA 600:41/01-010/19/12_35) | HSA 6004101-010-19-12_35 FSN_Redacted [PDF, 181 KB] (opens in new tab) |
6 May 2019 | 6F Sherpa NX Active Catheters, Medtronic Inc (HSA 600:41/01-009/19/06_66) | HSA 6004101-009-19-06_66 FSN [PDF, 482 KB] (opens in new tab) |
3 May 2019 | CS-430.1 Sepax Kit Sterility indicator, Biosafe SA (HSA 600:41/01-145/19/03_38) | HSA 6004101-145-19-03_38 FSN_Redacted [PDF, 521 KB] (opens in new tab) |
3 May 2019 | Philips Affiniti 70 Diagnostic Ultrasound Systems, Philips Affiniti Diagnostic Ultrasound System, Philips EPIQ Diagnostic Ultrasound System and Philips EPIQ Ultrasound System, Philips Ultrasound, Inc (HSA 600:41/01-026/19/14_66) | HSA 6004101-026-19-14_66 FSN_Redacted [PDF, 132 KB] (opens in new tab) |
3 May 2019 | Covidien Emprint™ Percutaneous and SX Navigation Antenna with Thermosphere™ Technology, Covidien llc (HSA 600:41/01-046/19/05_64) | HSA 6004101-046-19-05_64 FSN_Redacted [PDF, 188 KB] (opens in new tab) |
3 May 2019 | Coated Vicryl Plus Absorbable Surgical Suture, Ethicon, Inc (HSA 600:41/01-002/19/10_71) | HSA 6004101-002-19-10_71 FSN_Redacted [PDF, 170 KB] (opens in new tab) |
3 May 2019 | Ethicon PDS* PLUS Antibacterial (Polydioxanone) Suture, Ethicon, Inc (HSA 600:41/01-002/19/09_56) | HSA 6004101-002-19-09_56 FSN_Redacted [PDF, 190 KB] (opens in new tab) |
2 May 2019 | Thio Med w/Dex,Hem,Vit K and Thio Med w/Dex,Hemin,Vit K, Remel Inc (Thermo Fisher Scientific) (HSA 600:41/01-178/19/02_75) | HSA 6004101-178-19-02_75 FSN_Redacted [PDF, 117 KB] (opens in new tab) |
2 May 2019 | Aisys Anesthesia Devices and Aisys CS2 Anesthesia Devices, Datex-Ohmeda, Inc. (HSA 600:41/01-010/19/11_48) | HSA 6004101-010-19-11_48 FSN_Redacted [PDF, 147 KB] (opens in new tab) |
9 Apr 2019 | Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48) | HSA 6004101-026-19-11_48 FSN [PDF, 326 KB] (opens in new tab) This FSN is an update to the original FSN published in April 2019. |
21 Nov 2018 | Efficia 3/5 ECG Trunk Cable, Philips Goldway (Shenzhen) Industrial Inc. (HSA 600:41/01-026/18/32_62) Local Contact: Philips Electronics (S) Pte Ltd | HSA 6004101-026-18-32_62 FSN [PDF, 1446 KB] (opens in new tab) This updated FSN replaces the original FSN published in Nov 2018. |