Field Safety Notices
Field Safety Notice - Oct 2016
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 October 2016
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
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) | |
31 Oct 2016 | LMA MAD Nasal Intranasal Mucosal Atomization Device, Wolf Tory Medical, Inc (HSA 600:41/01-139/16/05_25) | |
31 Oct 2016 | Axiom Artis Systems and Artis Zee Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/16/50_19) | |
27 Oct 2016 | SOMA TOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH (HSA 600:41/01-022/16/49_46) | |
27 Oct 2016 | AssayTip/AssayCup, Roche Diagnostic GmbH (HSA 600:41/01-016/16/18_38) | |
27 Oct 2016 | Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/37_48) | |
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) | |
27 Oct 2016 | Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/38_17) | |
26 Oct 2016 | One Lambda LABType SSO and HD Typing Tests, One Lambda, Inc (HSA 600:41/01-033/16/07_34) | |
26 Oct 2016 | Nellix EndoVascular Aneurysm Sealing System, Endologix, Inc (HSA 600:41/01-057/16/05_54) | |
25 Oct 2016 | SynReam Reaming Rod, Synthes GmbH (HSA 600:41/01-002/16/35_63) | |
25 Oct 2016 | Knee Navigation System, Brainlab AG (HSA 600:41/01-047/15/09_51) | |
21 Oct 2016 | Fujifilm Synapse 4.0, FUJIFILM CORPORATION (HSA 600:41/01-173/16/03_41) | |
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) | |
20 Oct 2016 | Nihon Kohden Cardiolife AED Automated External Defibrillator, Nihon Kohden Corporation (HSA 600:41/01-074/16/01_35) | |
20 Oct 2016 | ADVIA Centaur CA 19-9, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/48_31) | |
19 Oct 2016 | EZ-Tip, Research Instruments Ltd (HSA 600:41/01-210/16/02_33) | |
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) | |
19 Oct 2016 | Monaco RTP System, IMPAC Medical Systems, Inc (HSA 600:41/01-101/16/08_45) | |
18 Oct 2016 | Vygon Lectroguard IV Extension Tube, Vygon SA (HSA 600:41/01-051/16/01_19) | |
17 Oct 2016 | Fujifilm Ultrasonic Video Endoscope, Fujifilm Corporation (HSA 600:41/01-173/16/02_36) | |
17 Oct 2016 | M.I Tech Choostent Covered Esophageal Stent, M.I. Tech Co Ltd (HSA 600:41/01-305/16/01_49) | |
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 | |
14 Oct 2016 | Bard SafeStep Huber Neede Set, Bard Access Systems, Inc. (HSA 600:41/01-050/16/07_08) Contact no./Email: 65805988 | |
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 | |
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 | |
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 | |
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 | |
12 Oct 2016 | Dialog+ Dialyzer machine, B. Braun Avitum AG (HSA 600:41/01-012/16/10_48) Contact no./Email: 62130933 | |
11 Oct 2016 | ARCHITECT Lactic Acid, Abbott Laboratories (HSA 600:41/01-005/16/10_61) Contact no./Email: 68859103 | |
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) | |
10 Oct 2016 | SenTec Digital Monitoring System (SMD), SenTec AG (HSA 600:41/01-199/16/02_54) | |
10 Oct 2016 | Boston Scientific Guider Softip Catheter XF, Boston Scientific Corporation (HSA 600:41/01-014/16/13_52) | |
7 Oct 2016 | ID-DiaCell I-II, DiaMed GmbH (HSA 600:41/01-027/16/11_60) | |
7 Oct 2016 | ICU TegoTM Needle-Free Access Device Connector, ICU Medical, Inc (HSA 600:41/01-145/16/02_51) | |
6 Oct 2016 | ADVIA Centaur Vitamin D Total, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/46_57) | |
6 Oct 2016 | IBA Proton Therapy Systems, Ion Beam Applications S.A. (HSA 600:41/01-070/16/20_40) | |
6 Oct 2016 | Low Profile Abutments, Biomet 3i (HSA 600:41/01-181/16/03_44) | |
6 Oct 2016 | ARCTIC SUN® 5000 Temperature Management System, C.R. Bard, Inc. (HSA 600:41/01-050/16/06_50) | |
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) | |
6 Oct 2016 | Tina-quant HbA1c Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/16_59) | |
5 Oct 2016 | Clearify Visualization System, Covidien llc (HSA 600:41/01-046/16/08_49) | |
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) | |
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) |