Field Safety Notices
Field Safety Notice - May 2016
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 May 2016
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
30 May 2016 | Larynx-Tubus LTS-D/Size 4, Single use, Sterile, VBM Medizintechnik GmbH (HSA 600:41/01-278/16/01_50) | |
30 May 2016 | BrightView X Imaging System, BrightView XCT Imaging System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/20_51) | |
30 May 2016 | CareFusion AVEA Ventilator, CareFusion/BD (HSA 600:41/01-056-16/05_41) | |
27 May 2016 | PTS Panels® CHOL+HDL+GLU Test Strips, Polymer Technology Systems Inc (HSA 600:41/01-186/16/01_58) | |
26 May 2016 | Adora X-ray Systems, NRT-NORDISK RONTGEN TEKNIK A/S (HSA 600:41/01-238/16/01_40) | |
26 May 2016 | ImmunoCAP Specific IgG/IgG4 i1 Control H, Thermofisher Scientific (HSA 600:41/01-033/16/04_38) | |
26 May 2016 | SERVO-i and SERVO-s ventilators, Maquet Critical Care AB (HSA 600:41/01-081/16/01_36) | |
26 May 2016 | Knee and Trauma Implant (Various), Zimmer Biomet (HSA 600:40/01-008/16/06_33) | |
26 May 2016 | Edwards EV1000 Clinical Platform, Edwards Lifesciences LLC (HSA 600:41/01-060/16/02_49) | |
26 May 2016 | Flexible Shaft Ø 8.0mm, L 360 mm for Extraction System for Solid Medullary Nails, Synthes GmbH (HSA 600:41/01-002/16/23_44) | |
25 May 2016 | 3.0T 6 Channel Flex Coil for MR750, MR750W and 3.0T HDxT (including HD23), GE Medical Systems LLC (HSA 600:41/01-010/15/22_36) | |
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) | |
25 May 2016 | Disposable paediatric ventilation circuit VentStar Oxylog3000F (P) 190 for Oxylog 3000 and Oxylog 3000 plus, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/16/02_17) | |
25 May 2016 | TIGR Matrix Surgical Mesh, Novus Scientific AB (HSA 600:41/01-298/16/01_37) | |
25 May 2016 | ETHICON PHYSIOMESH™ Flexible Composite Mesh, Johnson & Johnson International (HSA 600:41/01-002/16/22_35) | |
24 May 2016 | VITROS® Chemistry Products Ca Slides Generation 29, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/21_20) | |
24 May 2016 | UniCel DxH 800 & UniCel DxH 600 Coulter Cellular Analysis System, Beckman Coulter Inc (HSA 600:41/01-052/16/07_57) | |
24 May 2016 | LIFECODES HLA-C eRES SSO Typing Kit, Immucor Inc (HSA 600:41/01-070/16/14_22) | |
24 May 2016 | Teosyal® Ultimate and Teosyal® PureSense Ultimate, Teoxane SA (HSA 600:41/01-297/16/01_08) | |
23 May 2016 | Vancomycin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/09_61) | |
23 May 2016 | Bio-Rad Liquichek Cardiac Markers Plus Controls LT & Liquichek Cardiac Markers Plus Control, Bio-Rad Laboratories Diagnostics Group (HSA 600:41/01-027/16/05_60) | |
23 May 2016 | GENTAMICIN, Roche Diagnostics GmbH (HSA 600:41/01-016/16/08_59) | |
20 May 2016 | Saw Sagittal, Saw Sagittal Refurbished, Saw Sagittal Finger & Saw Sagittal Finger Refurbished, Medtronic Xomed (HSA 600:41/01-009/16/05_09) | |
19 May 2016 | VITROS Immunodiagnostic Products AFP Reagent Pack & AFP Calibrators, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/20_57) | |
19 May 2016 | Optima 1.5T MR430s, GE Healthcare (HSA 600:41/01-010/16/09_56) | |
18 May 2016 | Siemens Cios Alpha mobile C-arm X-Ray System, Siemens AG (HSA 600:41/01-022/16/25_48) | |
18 May 2016 | Oxoid Microbact Haemolysin Reagent MB1249A, Oxoid Limited (HSA 600:41/01-178/16/03_34) | |
18 May 2016 | Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/02_54) | |
17 May 2016 | ELISIO-19H, Nipro Medical (Hefei) Co. Ltd (HSA 600:41/01-233/16/02_63) | |
17 May 2016 | TRUEresult (GDH-FAD) Blood Glucose Test Strips, Nipro Diagnostics Inc (HSA 600:41/01-233/16/03_31) | |
16 May 2016 | cobas b 123 Sensor Cartridge BG/ISE, Roche Diagnostics GmbH (Ref: HSA 600:41/01-016/16/07_23) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact No.: 6272 7500 | |
16 May 2016 | Medtronic RestoreSensor Implantable Neurostimulators, Medtronic Inc. (Ref: HSA 600:41/01-009/16/04_51) Local Contact: Medtronic International Limited Contact No.: jason.ee@medtronic.com | |
13 May 2016 | COSEAL Surgical Sealant Kit, 2mL, COSEAL Surgical Sealant Kit, 4mL, Baxter Healthcare SA (Ref: HSA 600:41/01-001/16/03_41) Local Contact: Baxter Healthcare (Asia) Pte Ltd Contact No.: 68262616 | |
12 May 2016 | ORTHO VISION® Max Analyzer for ORTHO BioVue® Cassettes, Ortho Clinical Diagnostics (Ref: HSA 600:41/01-002/16/19_22) Local Contact: Johnson & Johnson Pte Ltd Contact No.: 68276135 | |
12 May 2016 | Threader Monorail Micro-Dilation Catheters and Threader Over the Wire Micro-Dilatation Catheters, Boston Scientific Corporation (Ref: HSA 600:41/01-007/16/03_40) Local Contact: Boston Scientific Asia Pacific Pte Ltd | |
12 May 2016 | Dimension Enzyme II Calibrator, Siemens Healthcare Diagnostics Inc. (Ref: HSA 600:41/01-022/16/24_60) Local Contact: Siemens Healthcare Pte Ltd | |
12 May 2016 | Cook Catheter with Beacon Tip FluoroSet® Radiographic Tubal Assessment Set Transluminal Biliary Biopsy Forceps Set, Cook Incorporated (Ref: HSA 600:41/01-013/16/03_25) Local Contact: Cook South East Asia Pte Ltd | |
12 May 2016 | LIFECODES LifeScreen Deluxe (LMX), Immucor, Inc (Ref: HSA 600:41/01-070/16/13_20) Local Contact: Transmedic Pte Ltd | |
11 May 2016 | STATLOCK IAB Stabilization Device, Datascope Corp (Ref: HSA 600:41/01-017/16/04_37) Local Contact: IDS Medical Systems (S) Pte Ltd | |
11 May 2016 | Beckman Coulter Digitoxin, Beckman Coulter Inc. (Ref: HSA 600:41/01-052/16/06_58) Local Contact: Beckman Coulter Singapore Pte Ltd | |
11 May 2016 | EliA CCP Positive Control, Thermofisher Scientific (Ref: HSA 600:41/01-033/16/03_59) Local Contact: Biomed Diagnostics Pte Ltd | |
11 May 2016 | Optimed Zelos PTA Balloon catheter, Optimed Medizinische Instrumente GmbH (Ref: HSA 600:41/01-045/16/01_33) Local Contact: Malex Medical Asia (S) Pte Ltd | |
10 May 2016 | Brillance 64, Ingenuity Core,Ingenuity Core 128 , Software version 3.5.4, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/17_29) Local Contact: Philips Electronics (S) Pte Ltd | |
10 May 2016 | 1) Philips Brilliance Computed Tomography X-ray System 2) Philips Ingenuity CT System, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/18_45) Local Contact: Philips Electronics (S) Pte Ltd | |
10 May 2016 | INGENUITY CT, INGENUITY CORE, INGENUITY CORE 128, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/16_19) Local Contact: Philips Electronics (S) Pte Ltd | |
10 May 2016 | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, Leica Biosystems Newcastle Ltd (Ref: HSA 600:41/01-126/16/04_57) Local Contact: Leica Microsystems (SEA) Pte Ltd | |
10 May 2016 | CADD® ADMINISTRATION SETS WITH FLOW STOP, Smiths Medical ASD, Inc. (Ref: HSA 600:41/01-017/16/03_18) Local Contact: IDS Medical Systems (S) Pte Ltd | |
09 May 2016 | FilmArray Blood Culture Identification (BCID) Panel reagents, BCID kits (RFIT-ASY-0126, RFIT-AST-0127, BioFire Diagnostics, LLC (Ref: HSA 600:41/01-146/16/02_38) Local Contact: BioMérieux Singapore Pte Ltd | |
06 May 2016 | Philips DuraDiagnost X-ray system, Philips Healthcare (Suzhou) Co., Ltd (Ref: HSA 600:41/01-026/16/14_56) | |
06 May 2016 | Philips MX 16-slice CT x-ray system software v1.1.4.21426, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/15_09) | |
05 May 2016 | ADVIA Chemistry XPT System, Siemens Healthcare Diagnostics Inc (Ref: HSA 600:41/01-022/16/23_34) | |
05 May 2016 | Agfa HealthCare DX-D600 Direct Radiography (DR) System, Agfa HealthCare N.V. (Ref: HSA 600:41/01-184/16/02_48) | |
05 May 2016 | CENTURION® FMS (Fluidics Management System) Pack for CENTURION® Vision System, Alcon Laboratories Inc (Ref: HSA 600:41/01-135/16/03_52) | |
05 May 2016 | Cordis PRECISE® PRO RX Nitinol Stent System (Carotid), Cordis (Ref: HSA 600:41/01-002/16/18_46) | |
05 May 2016 | ADVIA Centaur XPT System, Siemens Healthcare Diagnostics Inc (Ref: HSA 600:41/01-022/16/22_31) | |
04 May 2016 | VersaCut+ Tissue Morcellator, Lumenis Singapore Pte Ltd (HSA 600:41/01-295/16/01_50) | |
04 May 2016 | R3 0 Degree XLPE Acetabular Liner 32mm ID X OD 48mm, Smith & Nephew Inc (HSA 600:41/01-073/16/13_51) | |
04 May 2016 | G-scan Brio Magnetic Resonance System, Esaote SpA (HSA 600:41/01-263/16/03_43) | |
04 May 2016 | ADVIA Centaur Tnl_Ultra Assay [CC 16-12], Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/21_23) | |
03 May 2016 | Beckman Coulter Lactate, Uric Acid, Cholesterol, Enzymatic Creatinine, Lipase, Triglyceride, Beckman Coulter Inc. (HSA 600:41/01-052/16/05_22) | |
03 May 2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software versions v3.2.x, v3.3 and v3.4, Volcano Corporation (HSA 600:41/01-070/16/12_41) | |
03 May 2016 | Surefuser+, Nipro Corporation (HSA 600:41/01-233/16/01_49) |