Field Safety Notices
Field Safety Notice - Jul 2016
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 July 2016
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Date of Notification | Title | FSN |
|---|---|---|
28 Jul 2016 | Progressa® Bed (P7500) with P500 Microclimate Management™ Surface, Hill-Rom Inc (HSA 600:41/01-017/16/06_44) | |
28 Jul 2016 | STERRAD® 100NX™ Sterilizer, Advanced Sterilization Products (HSA 600:41/01-002/16/32_40) | |
27 Jul 2016 | Absorb™ and Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) Systems, Abbott Vascular (HSA 600:41/01-005/16/09_43) | |
27 Jul 2016 | Thermo Scientific Oxoid Columbia Blood Agar Base CM0331 (B,R,S,T,U), Oxoid Limited (HSA 600:41/01-178/16/05_60) | |
27 Jul 2016 | Ingenuity Core 128 with Software Version 3.5.5, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/16/29_36) | |
26 Jul 2016 | BD Tritest™ CD3 FITC/CD4 PE/CD45 PerCP, Becton, Dickinson and Company (HSA 600:41/01-003/16/07_58) | |
26 Jul 2016 | VIDAS Estradiol II, BioMerieux SA (HSA 600:41/01-146/16/07_61) | |
26 Jul 2016 | RENASYS™ Transparent Film, Smith & Nephew Inc (HSA 600:41/01-073/16/22_49) | |
26 Jul 2016 | Xprecia Stride Coagulation Analyzer, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/34_59) | |
25 Jul 2016 | Aptissen HealaFlow, Aptissen SA (HSA 600:41/01-261/16/01_33) | |
25 Jul 2016 | Fixture 1002.65A0, Maquet GmbH (HSA 600:41/01-017/16/05_45) | |
22 Jul 2016 | OptraPol Cup Refill, Ivoclar Vivadent AG (HSA 600:41/01-067/16/02_19) | |
21 Jul 2016 | NucliSENS easyMAG, bioMérieux SA (HSA 600:41/01-146/16/06_38) | |
21 Jul 2016 | Novus Scientific TIGR® Matrix Surgical Mesh, Novus Scientific AB (HSA 600:41/01-298/16/02_18) | |
20 Jul 2016 | Locking Screw Stardrive® Ø 2.4 mm, self-tapping, length 12 mm, TAN (Sterile & Non-Sterile), Synthes GmbH (HSA 600:41/01-002/16/31_09) | |
20 Jul 2016 | Homepump C - Series Silicone Elastomeric Pumps, Halyard Health Inc (HSA 600:41/01-012/16/07_17) | |
19 Jul 2016 | VITROS Immunodiagnostic Products Estradiol Reagent Pack, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/30_34) | |
18 Jul 2016 | O-arm 1000 and O2 Imaging Systems, Medtronic Navigation Inc (HSA 600:41/01-009/16/13_48) | |
18 Jul 2016 | Multidiagnost Eleva, MultiDiagnost Eleva with Flat Detector and UroDiagnost Eleva systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/28_46) | |
18 Jul 2016 | TrueBeam® Radiotherapy Delivery System with AlignRT®, Varian Medical Systems (HSA 600:41/01-058/16/03_56) | |
15 Jul 2016 | Smith & Nephew TriGen Internal Hex Captured Recon Screw Blue 6.4MM x 65MM, Smith & Nephew Inc. (HSA 600:41/01-073/16/21_52) Contact no./Email: singapore.surgicalsale@smith-nephew.com | |
15 Jul 2016 | Quickie Q7 Rigid Wheelchair, Sunrise Medical(US) LLC (HSA 600:41/01-300/01/01_54) Contact no./Email: joe@dnrwheels.com | |
15 Jul 2016 | Adapter for Colibri, for Electric Pen Drive and Adapter, small, for Colibri (II) and Small Battery Drive (II), Synthes GmbH (HSA 600:41/01-002/16/29_43) Contact no./Email: bsee@its.jnj.com | |
14 Jul 2016 | RaySearch Laboratories RayStation, RaySearch Laboratories AB (HSA 600:41/01-070/16/16_50) Contact no./Email: regulatory@transmedicgroup.com | |
14 Jul 2016 | Medtronic DBS Pocket Adaptor Models 64001 and 64002, Medtronic Inc (Neuromodulation) (HSA 600:41/01-009/16/12_63) Contact no./Email: 64396849 | |
14 Jul 2016 | Artis Zee Family System, Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/16/32_51) Contact no./Email: ui-handling.sg@siemens.com | |
14 Jul 2016 | Artis systems with 19" Live Display, Siemens Healthcare GmbH (HSA 600:41/01-022/16/31_41) Contact no./Email: ui-handling.sg@siemens.com | |
13 Jul 2016 | Perfusor Line, PVC, LL, 150 cm, B Braun Melsungen AG (HSA 600:41/01-012/16/06_40) Contact no./Email: 6213 0933 | |
13 Jul 2016 | cobas b 123 Neonatal Bilirubin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/12_31) | |
12 Jul 2016 | TAPERLOC HIP LATERALISED PC STEM 15.0MM 12/14 TAPER, TAPERLOC HIP LATERALISED PC STEM 17.5MM 12/14 TAPER, Biomet UK Limited (HSA 600:41/01-008/16/08_44) | |
12 Jul 2016 | NOVOSYN VIOLET 1 (4) 90cm HR40S, B. Braun Surgical SA (HSA 600:41/01-012/16/05_49) | |
11 Jul 2016 | Covidien ValleyLab Laparoscopic Electrodes, Covidien llc (HSA 600:41/01-046/16/06_36) | |
11 Jul 2016 | Reflection Spherical Head Screw 25mm, Smith & Nephew Inc (HSA 600:41/01-073/16/18_33) | |
11 Jul 2016 | Genesis Trocar Pin, Smith & Nephew Inc (HSA 600:41/01-073/16/19_37) | |
11 Jul 2016 | DYONICS SMALL SAGITTAL BLADE 9.5x, Smith & Nephew Inc (HSA 600:41/01-073/16/20_35) | |
8 Jul 2016 | ID-DiaCell I-II-III Asia, DiaMed GmbH (HSA 600:41/01-027/16/08_22) | |
8 Jul 2016 | ThermoScientific Oxoid GC Agar, CM0367 (B, R, T, Q), Oxoid Limited (HSA 600:41/01-178/16/04_60) | |
8 Jul 2016 | CELL-DYN Emerald Cleaner, Abbott Laboratories (HSA 600:41/01-005/16/08_23) | |
8 Jul 2016 | Temporary Transvenous Pacing Lead System, Medtronic Inc (HSA 600:41/01-009/16/11_45) | |
5 Jul 2016 | SAFIL QUI+ UNDY 5/0 (1) 45CM DSMP13(M) DDP, B. Braun Surgical SA (HSA 600:41/01-012/16/04_25) | |
5 Jul 2016 | Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mm, Synthes GmbH (HSA 600:41/01-002/16/27_18) | |
5 Jul 2016 | Heater Cooler 1T, Heater Cooler 3T and FlexTherm devices, SORIN Group Deutschland GmbH (HSA 600:41/01-299/16/01_19) | |
4 Jul 2016 | MOSAIQ, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/04_17) | |
4 Jul 2016 | BD Trucount Absolute Counting Tubes (IVD), Becton Dickinson and Company (HSA 600:41/01-003/16/06_59) | |
1 Jul 2016 | Philips MX 16-Slice CT Scanner System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/27_43) | |
1 Jul 2016 | Mueller Hinton + 5 % horse blood agar + 20 mg/l bêta-NAD, bioMérieux SA (HSA 600:41/01-146/16/05_58) | |
1 Jul 2016 | NIM® Standard Reinforced EMG Endotracheal Tube, Medtronic Xomed Inc (HSA 600:41/01-009/16/10_51) | |
1 Jul 2016 | Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow, Synthes GmbH(HSA 600:41/01-002/16/26_50) |