Field Safety Notices
Field Safety Notice - Oct 2016
31 October 2016
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
DATE OF NOTIFICATION | TITLE | FSN |
|---|---|---|
31 Oct 2016 | Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/16/51_45) | HSA 6004101-022-16-51_45 FSN [PDF, 1548 KB] (opens in new tab) |
31 Oct 2016 | LMA MAD Nasal Intranasal Mucosal Atomization Device, Wolf Tory Medical, Inc (HSA 600:41/01-139/16/05_25) | HSA 6004101-139-16-05_25 FSN [PDF, 428 KB] (opens in new tab) |
31 Oct 2016 | Axiom Artis Systems and Artis Zee Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/16/50_19) | HSA 6004101-022-16-50_19 FSN [PDF, 1419 KB] (opens in new tab) HSA 6004101-022-16-50_19 FSN [PDF, 1730 KB] (opens in new tab) |
27 Oct 2016 | SOMA TOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH (HSA 600:41/01-022/16/49_46) | HSA 6004101-022-16-49_46 FSN [PDF, 3284 KB] (opens in new tab) |
27 Oct 2016 | AssayTip/AssayCup, Roche Diagnostic GmbH (HSA 600:41/01-016/16/18_38) | HSA 6004101-016-16-18_38 FSN [PDF, 192 KB] (opens in new tab) |
27 Oct 2016 | Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/37_48) | HSA 6004101-026-16-37_48 FSN [PDF, 208 KB] (opens in new tab) |
27 Oct 2016 | X-Force™ Nephrostomy Balloon Dilation Catheter Kit With Inflation Device, C.R. Bard, Inc (HSA 600:41/01-050/16/09_56) | HSA 6004101-050-16-09_56 FSN [PDF, 403 KB] (opens in new tab) |
27 Oct 2016 | Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/38_17) | HSA 6004101-026-16-38_17 FSN [PDF, 241 KB] (opens in new tab) |
26 Oct 2016 | One Lambda LABType SSO and HD Typing Tests, One Lambda, Inc (HSA 600:41/01-033/16/07_34) | HSA 6004101-033-16-07_34 FSN [PDF, 147 KB] (opens in new tab) |
26 Oct 2016 | Nellix EndoVascular Aneurysm Sealing System, Endologix, Inc (HSA 600:41/01-057/16/05_54) | HSA 6004101-057-16-05_54 FSN [PDF, 901 KB] (opens in new tab) |
25 Oct 2016 | SynReam Reaming Rod, Synthes GmbH (HSA 600:41/01-002/16/35_63) | HSA 6004101-002-16-35_63 FSN [PDF, 2097 KB] (opens in new tab) |
25 Oct 2016 | Knee Navigation System, Brainlab AG (HSA 600:41/01-047/15/09_51) | HSA 6004101-047-15-09_51 FSN [PDF, 311 KB] (opens in new tab) |
21 Oct 2016 | Fujifilm Synapse 4.0, FUJIFILM CORPORATION (HSA 600:41/01-173/16/03_41) | HSA 6004101-173-16-03_41 FSN [PDF, 152 KB] (opens in new tab) |
21 Oct 2016 | Bard® Fluoro-4 Silicone Figure Four Coil, InLay, InLay VersaFit, InLay Optima Ureteral Stent, C.R. Bard, Inc (HSA 600:41/01-050/16/08_44) | HSA 6004101-050-16-08_44 FSN [PDF, 282 KB] (opens in new tab) |
20 Oct 2016 | Nihon Kohden Cardiolife AED Automated External Defibrillator, Nihon Kohden Corporation (HSA 600:41/01-074/16/01_35) | HSA 6004101-074-16-01_35 FSN [PDF, 1650 KB] (opens in new tab) |
20 Oct 2016 | ADVIA Centaur CA 19-9, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/48_31) | HSA 6004101-022-16-48_31 FSN [PDF, 615 KB] (opens in new tab) |
19 Oct 2016 | EZ-Tip, Research Instruments Ltd (HSA 600:41/01-210/16/02_33) | HSA 6004101-210-16-02_33 FSN [PDF, 111 KB] (opens in new tab) |
19 Oct 2016 | Philips Achieva 3.0T and Ingenia 3.0T MR, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/16/36_25) | HSA 6004101-026-16-36_25 FSN [PDF, 245 KB] (opens in new tab) |
19 Oct 2016 | Monaco RTP System, IMPAC Medical Systems, Inc (HSA 600:41/01-101/16/08_45) | HSA 6004101-101-16-08_45 FSN [PDF, 63 KB] (opens in new tab) |
18 Oct 2016 | Vygon Lectroguard IV Extension Tube, Vygon SA (HSA 600:41/01-051/16/01_19) | HSA 6004101-051-16-01_19 FSN [PDF, 355 KB] (opens in new tab) |
17 Oct 2016 | Fujifilm Ultrasonic Video Endoscope, Fujifilm Corporation (HSA 600:41/01-173/16/02_36) | HSA 6004101-173-16-02_36 FSN [PDF, 50 KB] (opens in new tab) |
17 Oct 2016 | M.I Tech Choostent Covered Esophageal Stent, M.I. Tech Co Ltd (HSA 600:41/01-305/16/01_49) | HSA 6004101-305-16-01_49 FSN [PDF, 4652 KB] (opens in new tab) |
14 Oct 2016 | VITROS Chemistry Products Calibrator Kit 25, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/02_22) Contact no./Email: 64861151 | HSA 6004101-303-16-02_22 FSN [PDF, 338 KB] (opens in new tab) |
14 Oct 2016 | Bard SafeStep Huber Neede Set, Bard Access Systems, Inc. (HSA 600:41/01-050/16/07_08) Contact no./Email: 65805988 | HSA 6004101-050-16-07_08 FSN [PDF, 201 KB] (opens in new tab) |
14 Oct 2016 | ADVIA® Chemistry Direct BilirubinAssay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/47_23) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com | HSA 6004101-022-16-47_23 FSN [PDF, 276 KB] (opens in new tab) |
13 Oct 2016 | GE BRIVO OEC 715/785/865, GE Hangwei Medical Systems Co., Ltd (HSA 600:41/01-010/16/16_62) Contact no./Email: 62777668 | HSA 6004101-010-16-16_62 FSN [PDF, 291 KB] (opens in new tab) |
13 Oct 2016 | Ortho-Clinical VITROS Immunodiagnostic Products Intact PTH Reagent Pack, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/01_65) Contact no./Email: 64861151 | HSA 6004101-303-16-01_65_FSN [PDF, 157 KB] (opens in new tab) |
13 Oct 2016 | Standard Offset Cup Impactor With Pom-C Handle, Greatbatch Medical (HSA 600:41/01-014/16/14_56) Contact no./Email: ASEAN.PMS@stryker.com | HSA 6004101-014-16-14_56 FSN [PDF, 389 KB] (opens in new tab) |
12 Oct 2016 | Dialog+ Dialyzer machine, B. Braun Avitum AG (HSA 600:41/01-012/16/10_48) Contact no./Email: 62130933 | HSA 6004101-012-16-10_48 FSN [PDF, 4150 KB] (opens in new tab) |
11 Oct 2016 | ARCHITECT Lactic Acid, Abbott Laboratories (HSA 600:41/01-005/16/10_61) Contact no./Email: 68859103 | HSA 6004101-005-16-10_61 FSN [PDF, 26 KB] (opens in new tab) |
11 Oct 2016 | Fortify™, Fortify Assura™, Quadra Assura™,Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™, St Jude Medical (HSA 600:41/01-025/16/02_46) | HSA 6004101-025-16-02_46 FSN [PDF, 58 KB] (opens in new tab) |
10 Oct 2016 | SenTec Digital Monitoring System (SMD), SenTec AG (HSA 600:41/01-199/16/02_54) | HSA 6004101-199-16-02_54 FSN [PDF, 301 KB] (opens in new tab) |
10 Oct 2016 | Boston Scientific Guider Softip Catheter XF, Boston Scientific Corporation (HSA 600:41/01-014/16/13_52) | HSA 6004101-014-16-13_52 FSN [PDF, 33 KB] (opens in new tab) |
7 Oct 2016 | ID-DiaCell I-II, DiaMed GmbH (HSA 600:41/01-027/16/11_60) | HSA 6004101-027-16-11_60 FSN [PDF, 1560 KB] (opens in new tab) |
7 Oct 2016 | ICU TegoTM Needle-Free Access Device Connector, ICU Medical, Inc (HSA 600:41/01-145/16/02_51) | HSA 6004101-145-16-02_51 FSN [PDF, 349 KB] (opens in new tab) |
6 Oct 2016 | ADVIA Centaur Vitamin D Total, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/46_57) | HSA 6004101-022-16-46_57 FSN [PDF, 107 KB] (opens in new tab) |
6 Oct 2016 | IBA Proton Therapy Systems, Ion Beam Applications S.A. (HSA 600:41/01-070/16/20_40) | HSA 6004101-070-16-20_40 FSN [PDF, 254 KB] (opens in new tab) |
6 Oct 2016 | Low Profile Abutments, Biomet 3i (HSA 600:41/01-181/16/03_44) | HSA 6004101-181-16-03_44 FSN [PDF, 166 KB] (opens in new tab) |
6 Oct 2016 | ARCTIC SUN® 5000 Temperature Management System, C.R. Bard, Inc. (HSA 600:41/01-050/16/06_50) | HSA 6004101-050-16-06_50 FSN [PDF, 606 KB] (opens in new tab) |
6 Oct 2016 | Pipeline embolization device,Alligator retrieval device,Marathon microcatheter stylets,UltraFlow HPC microcatheter stylets andXcelerator hydrophilic guidewire, Micro Therapeutics Inc dba eV3 Neurovascular (HSA 600:41/01-046/16/09_41) | HSA 6004101-046-16-09_41 FSN [PDF, 2482 KB] (opens in new tab) |
6 Oct 2016 | Tina-quant HbA1c Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/16_59) | HSA 6004101-016-16-16_59 FSN [PDF, 287 KB] (opens in new tab) |
5 Oct 2016 | Clearify Visualization System, Covidien llc (HSA 600:41/01-046/16/08_49) | HSA 6004101-046-16-08_49 FSN [PDF, 1542 KB] (opens in new tab) |
28 Jun 2016 | API 3200MD LC/MS/MS system, 3200MD Qtrap LC/MS/MS system, Triple Quad 4500MD LC/MS/MS system and Qtrap LC/MS/MS system, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/03_38) | HSA 6004101-255-16-03_38 FSN [PDF, 150 KB] (opens in new tab) |
25 May 2016 | da Vinci Xi 5 mm-8 mm Universal Cannula Seal, da Vinci Xi 12 mm & Stapler Universal Cannula Seal, Intuitive Surgical Inc (HSA 600:41/01-070/16/15_29) | HSA 6004101-070-16-15_29 FSN [PDF, 4825 KB] (opens in new tab) |