Field Safety Notices
Field Safety Notice - Jul 2016
31 July 2016
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
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) | HSA 6004101-017-16-06_44 FSN [PDF, 708 KB] (opens in new tab) |
28 Jul 2016 | STERRAD® 100NX™ Sterilizer, Advanced Sterilization Products (HSA 600:41/01-002/16/32_40) | HSA 6004101-002-16-32_40 FSN [PDF, 132 KB] (opens in new tab) |
27 Jul 2016 | Absorb™ and Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) Systems, Abbott Vascular (HSA 600:41/01-005/16/09_43) | HSA 6004101-005-16-09_43 FSN [PDF, 859 KB] (opens in new tab) |
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) | HSA 6004101-178-16-05_60 FSN [PDF, 219 KB] (opens in new tab) |
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) | HSA 6004101-026-16-29_36 FSN [PDF, 134 KB] (opens in new tab) |
26 Jul 2016 | BD Tritest™ CD3 FITC/CD4 PE/CD45 PerCP, Becton, Dickinson and Company (HSA 600:41/01-003/16/07_58) | HSA 6004101-003-16-07_58 FSN [PDF, 92 KB] (opens in new tab) |
26 Jul 2016 | VIDAS Estradiol II, BioMerieux SA (HSA 600:41/01-146/16/07_61) | HSA 6004101-146-16-07_61 FSN [PDF, 446 KB] (opens in new tab) |
26 Jul 2016 | RENASYS™ Transparent Film, Smith & Nephew Inc (HSA 600:41/01-073/16/22_49) | HSA 6004101-073-16-22_49 FSN [PDF, 271 KB] (opens in new tab) |
26 Jul 2016 | Xprecia Stride Coagulation Analyzer, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/34_59) | HSA 6004101-022-16-34_59 FSN [PDF, 17 KB] (opens in new tab) |
25 Jul 2016 | Aptissen HealaFlow, Aptissen SA (HSA 600:41/01-261/16/01_33) | HSA 6004101-261-16-01_33 FSN [PDF, 751 KB] (opens in new tab) |
25 Jul 2016 | Fixture 1002.65A0, Maquet GmbH (HSA 600:41/01-017/16/05_45) | HSA 6004101-017-16-05_45 FSN [PDF, 1225 KB] (opens in new tab) |
22 Jul 2016 | OptraPol Cup Refill, Ivoclar Vivadent AG (HSA 600:41/01-067/16/02_19) | HSA 6004101-067-16-02_19 FSN [PDF, 268 KB] (opens in new tab) |
21 Jul 2016 | NucliSENS easyMAG, bioMérieux SA (HSA 600:41/01-146/16/06_38) | HSA 6004101-146-16-06_38 FSN [PDF, 90 KB] (opens in new tab) |
21 Jul 2016 | Novus Scientific TIGR® Matrix Surgical Mesh, Novus Scientific AB (HSA 600:41/01-298/16/02_18) | HSA 6004101-298-16-02_18 FSN [PDF, 146 KB] (opens in new tab) |
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) | HSA 6004101-002-16-31_09 FSN [PDF, 81 KB] (opens in new tab) |
20 Jul 2016 | Homepump C - Series Silicone Elastomeric Pumps, Halyard Health Inc (HSA 600:41/01-012/16/07_17) | HSA 6004101-012-16-07_17 FSN [PDF, 115 KB] (opens in new tab) |
19 Jul 2016 | VITROS Immunodiagnostic Products Estradiol Reagent Pack, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/30_34) | HSA 6004101-002-16-30_34 FSN [PDF, 131 KB] (opens in new tab) |
18 Jul 2016 | O-arm 1000 and O2 Imaging Systems, Medtronic Navigation Inc (HSA 600:41/01-009/16/13_48) | HSA 6004101-009-16-13_48 FSN [PDF, 678 KB] (opens in new tab) HSA 6004101-009-16-13_48 FSN [PDF, 1393 KB] (opens in new tab) |
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) | HSA 6004101-026-16-28_46 FSN [PDF, 435 KB] (opens in new tab) |
18 Jul 2016 | TrueBeam® Radiotherapy Delivery System with AlignRT®, Varian Medical Systems (HSA 600:41/01-058/16/03_56) | HSA 6004101-058-16-03_56 FSN [PDF, 95 KB] (opens in new tab) |
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 | HSA 6004101-073-16-21_52 FSN [PDF, 124 KB] (opens in new tab) |
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 | HSA 6004101-300-16-01_54 FSN [PDF, 6411 KB] (opens in new tab) |
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 | HSA 6004101-002-16-29_43 FSN [PDF, 204 KB] (opens in new tab) |
14 Jul 2016 | RaySearch Laboratories RayStation, RaySearch Laboratories AB (HSA 600:41/01-070/16/16_50) Contact no./Email: regulatory@transmedicgroup.com | HSA 6004101-070-16-16_50 FSN [PDF, 494 KB] (opens in new tab) |
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 | HSA 6004101-009-16-12_63 FSN [PDF, 284 KB] (opens in new tab) |
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 | HSA 6004101-022-16-32_51 FSN [PDF, 1427 KB] (opens in new tab) |
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 | HSA 6004101-022-16-31_41 FSN [PDF, 1283 KB] (opens in new tab) |
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 | HSA 6004101-012-16-06_40 FSN [PDF, 40 KB] (opens in new tab) |
13 Jul 2016 | cobas b 123 Neonatal Bilirubin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/12_31) | HSA 6004101-016-16-12_31 FSN [PDF, 465 KB] (opens in new tab) |
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) | HSA 6004101-008-16-08_44 FSN [PDF, 3861 KB] (opens in new tab) |
12 Jul 2016 | NOVOSYN VIOLET 1 (4) 90cm HR40S, B. Braun Surgical SA (HSA 600:41/01-012/16/05_49) | HSA 6004101-012-16-05_49 FSN [PDF, 131 KB] (opens in new tab) |
11 Jul 2016 | Covidien ValleyLab Laparoscopic Electrodes, Covidien llc (HSA 600:41/01-046/16/06_36) | HSA 6004101-046-16-06_36 FSN [PDF, 1330 KB] (opens in new tab) |
11 Jul 2016 | Reflection Spherical Head Screw 25mm, Smith & Nephew Inc (HSA 600:41/01-073/16/18_33) | HSA 6004101-073-16-18_33 FSN [PDF, 80 KB] (opens in new tab) |
11 Jul 2016 | Genesis Trocar Pin, Smith & Nephew Inc (HSA 600:41/01-073/16/19_37) | HSA 6004101-073-16-19_37 FSN [PDF, 156 KB] (opens in new tab) |
11 Jul 2016 | DYONICS SMALL SAGITTAL BLADE 9.5x, Smith & Nephew Inc (HSA 600:41/01-073/16/20_35) | HSA 6004101-073-16-20_35 FSN [PDF, 64 KB] (opens in new tab) |
8 Jul 2016 | ID-DiaCell I-II-III Asia, DiaMed GmbH (HSA 600:41/01-027/16/08_22) | HSA 6004101-027-16-08_22 FSN [PDF, 1681 KB] (opens in new tab) |
8 Jul 2016 | ThermoScientific Oxoid GC Agar, CM0367 (B, R, T, Q), Oxoid Limited (HSA 600:41/01-178/16/04_60) | HSA 6004101-178-16-04_60 FSN [PDF, 293 KB] (opens in new tab) |
8 Jul 2016 | CELL-DYN Emerald Cleaner, Abbott Laboratories (HSA 600:41/01-005/16/08_23) | HSA 6004101-005-16-08_23 FSN [PDF, 71 KB] (opens in new tab) |
8 Jul 2016 | Temporary Transvenous Pacing Lead System, Medtronic Inc (HSA 600:41/01-009/16/11_45) | HSA 6004101-009-16-11_45 FSN [PDF, 369 KB] (opens in new tab) |
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) | HSA 6004101-012-16-04_25 FSN [PDF, 918 KB] (opens in new tab) |
5 Jul 2016 | Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mm, Synthes GmbH (HSA 600:41/01-002/16/27_18) | HSA 6004101-002-16-27_18 FSN [PDF, 152 KB] (opens in new tab) |
5 Jul 2016 | Heater Cooler 1T, Heater Cooler 3T and FlexTherm devices, SORIN Group Deutschland GmbH (HSA 600:41/01-299/16/01_19) | HSA 6004101-299-16-01_19 FSN [PDF, 86 KB] (opens in new tab) |
4 Jul 2016 | MOSAIQ, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/04_17) | HSA 6004101-101-16-04_17 FSN [PDF, 54 KB] (opens in new tab) |
4 Jul 2016 | BD Trucount Absolute Counting Tubes (IVD), Becton Dickinson and Company (HSA 600:41/01-003/16/06_59) | HSA 6004101-003-16-06_59 FSN [PDF, 2190 KB] (opens in new tab) |
1 Jul 2016 | Philips MX 16-Slice CT Scanner System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/27_43) | HSA 6004101-026-16-27_43 FSN [PDF, 303 KB] (opens in new tab) |
1 Jul 2016 | Mueller Hinton + 5 % horse blood agar + 20 mg/l bêta-NAD, bioMérieux SA (HSA 600:41/01-146/16/05_58) | HSA 6004101-146-16-05_58 FSN [PDF, 373 KB] (opens in new tab) |
1 Jul 2016 | NIM® Standard Reinforced EMG Endotracheal Tube, Medtronic Xomed Inc (HSA 600:41/01-009/16/10_51) | HSA 6004101-009-16-10_51 FSN [PDF, 474 KB] (opens in new tab) |
1 Jul 2016 | Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow, Synthes GmbH(HSA 600:41/01-002/16/26_50) | HSA 6004101-002-16-26_50 FSN [PDF, 298 KB] (opens in new tab) |