Field Safety Notices
Field Safety Notice - May 2016
31 May 2016
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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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) | HSA 6004101-278-16-01_50 FSN [PDF, 102 KB] (opens in new tab) |
30 May 2016 | BrightView X Imaging System, BrightView XCT Imaging System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/20_51) | HSA 6004101-026-16-20_51 FSN [PDF, 110 KB] (opens in new tab) |
30 May 2016 | CareFusion AVEA Ventilator, CareFusion/BD (HSA 600:41/01-056-16/05_41) | HSA 6004101-056-16-05_41 FSN [PDF, 1425 KB] (opens in new tab) |
27 May 2016 | PTS Panels® CHOL+HDL+GLU Test Strips, Polymer Technology Systems Inc (HSA 600:41/01-186/16/01_58) | HSA 6004101-186-16-01_58 FSN [PDF, 342 KB] (opens in new tab) |
26 May 2016 | Adora X-ray Systems, NRT-NORDISK RONTGEN TEKNIK A/S (HSA 600:41/01-238/16/01_40) | HSA 6004101-238-16-01_40 FSN [PDF, 2753 KB] (opens in new tab) |
26 May 2016 | ImmunoCAP Specific IgG/IgG4 i1 Control H, Thermofisher Scientific (HSA 600:41/01-033/16/04_38) | HSA 6004101-033-16-04_38 FSN [PDF, 215 KB] (opens in new tab) |
26 May 2016 | SERVO-i and SERVO-s ventilators, Maquet Critical Care AB (HSA 600:41/01-081/16/01_36) | HSA 6004101-081-16-01_36 FSN [PDF, 332 KB] (opens in new tab) |
26 May 2016 | Knee and Trauma Implant (Various), Zimmer Biomet (HSA 600:40/01-008/16/06_33) | HSA 6004101-008-16-06_33 FSN [PDF, 103 KB] (opens in new tab) |
26 May 2016 | Edwards EV1000 Clinical Platform, Edwards Lifesciences LLC (HSA 600:41/01-060/16/02_49) | HSA 6004101-060-16-02_49 FSN [PDF, 883 KB] (opens in new tab) |
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) | HSA 6004101-002-16-23_44 FSN [PDF, 71 KB] (opens in new tab) |
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) | HSA 6004101-010-15-22_36 FSN [PDF, 359 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, 152 KB] (opens in new tab) |
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) | HSA 6004101-063-16-02_17 FSN [PDF, 716 KB] (opens in new tab) |
25 May 2016 | TIGR Matrix Surgical Mesh, Novus Scientific AB (HSA 600:41/01-298/16/01_37) | HSA 6004101-298-16-01_37 FSN [PDF, 1450 KB] (opens in new tab) |
25 May 2016 | ETHICON PHYSIOMESH™ Flexible Composite Mesh, Johnson & Johnson International (HSA 600:41/01-002/16/22_35) | HSA 6004101-002-16-22_35 FSN [PDF, 221 KB] (opens in new tab) |
24 May 2016 | VITROS® Chemistry Products Ca Slides Generation 29, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/21_20) | HSA 6004101-002-16-21_20 FSN [PDF, 128 KB] (opens in new tab) |
24 May 2016 | UniCel DxH 800 & UniCel DxH 600 Coulter Cellular Analysis System, Beckman Coulter Inc (HSA 600:41/01-052/16/07_57) | HSA 6004101-052-16-07_57 FSN [PDF, 77 KB] (opens in new tab) |
24 May 2016 | LIFECODES HLA-C eRES SSO Typing Kit, Immucor Inc (HSA 600:41/01-070/16/14_22) | HSA 6004101-070-16-14_22 FSN [PDF, 225 KB] (opens in new tab) |
24 May 2016 | Teosyal® Ultimate and Teosyal® PureSense Ultimate, Teoxane SA (HSA 600:41/01-297/16/01_08) | HSA 6004101-297-16-01_08 FSN [PDF, 119 KB] (opens in new tab) |
23 May 2016 | Vancomycin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/09_61) | HSA 6004101-016-16-09_61 FSN [PDF, 90 KB] (opens in new tab) |
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) | HSA 6004101-027-16-05_60 FSN [PDF, 179 KB] (opens in new tab) |
23 May 2016 | GENTAMICIN, Roche Diagnostics GmbH (HSA 600:41/01-016/16/08_59) | HSA 6004101-016-16-08_59 FSN [PDF, 476 KB] (opens in new tab) |
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) | HSA 6004101-009-16-05_09 FSN [PDF, 1706 KB] (opens in new tab) |
19 May 2016 | VITROS Immunodiagnostic Products AFP Reagent Pack & AFP Calibrators, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/20_57) | HSA 6004101-002-16-20_57 FSN [PDF, 136 KB] (opens in new tab) |
19 May 2016 | Optima 1.5T MR430s, GE Healthcare (HSA 600:41/01-010/16/09_56) | HSA 6004101-010-16-09_56 FSN [PDF, 282 KB] (opens in new tab) |
18 May 2016 | Siemens Cios Alpha mobile C-arm X-Ray System, Siemens AG (HSA 600:41/01-022/16/25_48) | HSA 6004101-022-16-25_48 FSN [PDF, 85 KB] (opens in new tab) |
18 May 2016 | Oxoid Microbact Haemolysin Reagent MB1249A, Oxoid Limited (HSA 600:41/01-178/16/03_34) | HSA 6004101-178-16-03_34 FSN [PDF, 76 KB] (opens in new tab) |
18 May 2016 | Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/02_54) | HSA 6004101-101-16-02_54 FSN [PDF, 123 KB] (opens in new tab) |
17 May 2016 | ELISIO-19H, Nipro Medical (Hefei) Co. Ltd (HSA 600:41/01-233/16/02_63) | HSA 6004101-233-16-02_63 FSN [PDF, 2809 KB] (opens in new tab) |
17 May 2016 | TRUEresult (GDH-FAD) Blood Glucose Test Strips, Nipro Diagnostics Inc (HSA 600:41/01-233/16/03_31) | HSA 6004101-233-16-03_31 FSN [PDF, 66 KB] (opens in new tab) |
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 | HSA 6004101-016-16-07_23 FSN [PDF, 785 KB] (opens in new tab) |
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 | HSA 6004101-009-16-04_51 FSN [PDF, 216 KB] (opens in new tab) |
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 | HSA 6004101-001-16-03_41 FSN [PDF, 465 KB] (opens in new tab) |
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 | HSA 6004101-002-16-19_22 FSN [PDF, 62 KB] (opens in new tab) |
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 | HSA 6004101-007-16-03_40 FSN [PDF, 1842 KB] (opens in new tab) |
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 | HSA 6004101-022-16-24_60 FSN [PDF, 86 KB] (opens in new tab) |
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 | HSA 6004101-013-16-03_25 FSN [PDF, 444 KB] (opens in new tab) |
12 May 2016 | LIFECODES LifeScreen Deluxe (LMX), Immucor, Inc (Ref: HSA 600:41/01-070/16/13_20) Local Contact: Transmedic Pte Ltd | HSA 6004101-070-16-13_20 FSN [PDF, 223 KB] (opens in new tab) |
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 | HSA 6004101-017-16-04_37 FSN [PDF, 104 KB] (opens in new tab) |
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 | HSA 6004101-052-16-06_58 FSN [PDF, 85 KB] (opens in new tab) |
11 May 2016 | EliA CCP Positive Control, Thermofisher Scientific (Ref: HSA 600:41/01-033/16/03_59) Local Contact: Biomed Diagnostics Pte Ltd | HSA 6004101-033-16-03_59 FSN [PDF, 288 KB] (opens in new tab) |
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 | HSA 6004101-045-16-01_33 FSN [PDF, 4054 KB] (opens in new tab) |
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 | HSA 6004101-026-16-17_29 FSN [PDF, 32 KB] (opens in new tab) |
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 | HSA 6004101-026-16-18_45 FSN_ [PDF, 167 KB] (opens in new tab) HSA 6004101-026-16-18_45 FSN_ [PDF, 254 KB] (opens in new tab) |
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 | HSA 6004101-026-16-16_19 FSN [PDF, 405 KB] (opens in new tab) |
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 | HSA 6004101-126-16-04_57 FSN [PDF, 1676 KB] (opens in new tab) |
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 | HSA 6004101-017-16-03_18 FSN [PDF, 169 KB] (opens in new tab) |
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 | HSA 6004101-146-16-02_38 FSN [PDF, 500 KB] (opens in new tab) |
06 May 2016 | Philips DuraDiagnost X-ray system, Philips Healthcare (Suzhou) Co., Ltd (Ref: HSA 600:41/01-026/16/14_56) | HSA 6004101-026-16-14_56 FSN [PDF, 97 KB] (opens in new tab) HSA 6004101-026-16-14_56 FSN [PDF, 96 KB] (opens in new tab) |
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) | HSA 6004101-026-16-15_09 FSN [PDF, 308 KB] (opens in new tab) |
05 May 2016 | ADVIA Chemistry XPT System, Siemens Healthcare Diagnostics Inc (Ref: HSA 600:41/01-022/16/23_34) | HSA 6004101-022-16-23_34 FSN [PDF, 77 KB] (opens in new tab) |
05 May 2016 | Agfa HealthCare DX-D600 Direct Radiography (DR) System, Agfa HealthCare N.V. (Ref: HSA 600:41/01-184/16/02_48) | HSA 6004101-184-16-02_48 FSN [PDF, 61 KB] (opens in new tab) |
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) | HSA 6004101-135-16-03_52 FSN [PDF, 186 KB] (opens in new tab) |
05 May 2016 | Cordis PRECISE® PRO RX Nitinol Stent System (Carotid), Cordis (Ref: HSA 600:41/01-002/16/18_46) | HSA 6004101-002-16-18_46 FSN [PDF, 211 KB] (opens in new tab) |
05 May 2016 | ADVIA Centaur XPT System, Siemens Healthcare Diagnostics Inc (Ref: HSA 600:41/01-022/16/22_31) | HSA 6004101-022-16-22_31 FSN [PDF, 75 KB] (opens in new tab) |
04 May 2016 | VersaCut+ Tissue Morcellator, Lumenis Singapore Pte Ltd (HSA 600:41/01-295/16/01_50) | HSA 6004101-295-16-01_50 FSN [PDF, 121 KB] (opens in new tab) |
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) | HSA 6004101-073-16-13_51 FSN [PDF, 79 KB] (opens in new tab) |
04 May 2016 | G-scan Brio Magnetic Resonance System, Esaote SpA (HSA 600:41/01-263/16/03_43) | HSA 6004101-263-16-03_43 FSN [PDF, 2042 KB] (opens in new tab) |
04 May 2016 | ADVIA Centaur Tnl_Ultra Assay [CC 16-12], Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/21_23) | HSA 6004101-022-16-21_23 FSN [PDF, 109 KB] (opens in new tab) |
03 May 2016 | Beckman Coulter Lactate, Uric Acid, Cholesterol, Enzymatic Creatinine, Lipase, Triglyceride, Beckman Coulter Inc. (HSA 600:41/01-052/16/05_22) | HSA 6004101-052-16-05_22 FSN_Updated [PDF, 162 KB] (opens in new tab) |
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) | HSA 6004101-070-16-12_41 FSN [PDF, 1063 KB] (opens in new tab) |
03 May 2016 | Surefuser+, Nipro Corporation (HSA 600:41/01-233/16/01_49) | HSA 6004101-233-16-01_49 FSN [PDF, 98 KB] (opens in new tab) |