Field Safety Notices

Field Safety Notice - Dec 2015

31 December 2015

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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DATE OF NOTIFICATION	TITLE	FSN
30 Dec 2015	VerifyNow Aspirin Test Kits, Accumetrics Inc (HSA 600:41/01-246/15/01_34) Local Contact: Harmoni Prima Medika Pte Ltd Contact no./Email: 67496738	HSA 6004101-246-15-01_34 FSN [PDF, 3132 KB] (opens in new tab)
30 Dec 2015	CardioCall ECG Event Recorder, Spacelabs Healthcare Ltd (HSA 600:41/01-029/15/02_44) Local Contact: Spacelabs Healthcare Pte Ltd Contact no./Email: 68536300	HSA 6004101-029-15-02_44 FSN [PDF, 74 KB] (opens in new tab)
30 Dec 2015	Mavig Monitor suspensions installed on INNOVA 2000, INNOVA X100/IQ, INNOVA X1X1IQ, Advantx LCV+, Advantx LCA, Advantx LCLP+, Advantx LCN+ fluoroscopic imaging systems, GE Medical Systems SCS (HSA 600:41/01-010/15/25_52) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668	HSA 6004101-010-15-25_52 FSN [PDF, 85 KB] (opens in new tab)
30 Dec 2015	Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems, GE Medical Systems LLC (HSA 600:41/01-010/15/24_43) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668	HSA 6004101-010-15-24_43 FSN [PDF, 72 KB] (opens in new tab)
29 Dec 2015	Concerto Basic Shower Trolley, ArjoHuntleigh AB (HSA 600:41/01-065/15/01_51) Local Contact: ArjoHuntleigh Singapore Pte Ltd Contact no./Email: 62933387	HSA 6004101-065-15-01_51 FSN [PDF, 68 KB] (opens in new tab)
28 Dec 2015	Multiple dental abutment products and accessories, Biomet 3i (HSA 600:41/01-181/15/03_35) Local Contact: Asia Implant Support and Services Contact no./Email: 62232229	HSA 6004101-181-15-03_35 FSN [PDF, 535 KB] (opens in new tab)
28 Dec 2015	Nucleotron MicroSelection V3 remote controlled radionuclide applicator system, Nucletron B.V. (HSA 600:41/01-101/15/11_40) Local Contact: Elekta Pte Ltd Contact no./Email: 62212322	HSA 6004101-101-15-11_40 FSN [PDF, 143 KB] (opens in new tab)
28 Dec 2015	MOSAIQ, IMPAC Medical System Inc (HSA 600:41/01-101/15/10_36) Local Contact: Elekta Pte Ltd Contact no./Email: 62212322	HSA 6004101-101-15-10_36 FSN [PDF, 117 KB] (opens in new tab)
28 Dec 2015	Drive Gas Check Valve used with Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices, Datex-Ohmeda Inc (HSA 600:41/01-010/15/23_41) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668	HSA 6004101-010-15-23_41 FSN [PDF, 78 KB] (opens in new tab)
24 Dec 2015	Battery Power Line II Battery Oscillator, Synthes GmbH (HSA 600:41/01-002/15/62_37) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276459	HSA 6004101-002-15-62_37 FSN [PDF, 801 KB] (opens in new tab)
24 Dec 2015	Syngo Plaza, Siemens AG (HSA 600:41/01-022/15/64_25) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-64_25 FSN [PDF, 859 KB] (opens in new tab)
24 Dec 2015	D10 Rack Loader, Bio-Rad Laboratories Inc (HSA 600:41/01-027/15/06_24) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: jenny_tok@bio-rad.com	HSA 6004101-027-15-06_24 FSN [PDF, 415 KB] (opens in new tab)
24 Dec 2015	Antimicrobial Susceptibility Testing Disc - QD15 Quiupristin/Dalfopristin, Oxoid Limited (HSA 600:41/01-178/15/06_31) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999992	HSA 6004101-178-15-06_31 FSN [PDF, 76 KB] (opens in new tab)
22 Dec 2015	Nova T Copper Intrauterine Device, Bayer Pharma AG (HSA 600:41/01-066/15/01_48) Local Contact: Bayer South East Asia Pte Ltd Contact no./Email: medinfo.singapore@bayer.com	HSA 6004101-066-15-01_48 FSN [PDF, 36 KB] (opens in new tab)
22 Dec 2015	miraDry System, Miramar Labs Inc (HSA 600:41/01-119/15/03_56) Local Contact: Servicom Medical (Singapore) Pte Ltd Contact no./Email: inquiry@servicom.com.sg	HSA 6004101-119-15-03_56 FSN [PDF, 1351 KB] (opens in new tab)
21 Dec 2015	SYNTHES® Universal Tibial and Femoral Nail System, Synthes GmbH (HSA 600:41/01-002/15/60_46) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-60_46 FSN [PDF, 2497 KB] (opens in new tab)
21 Dec 2015	VITROS 250, VITROS 350, VITROS 5,1 FS, VITROS 4600 & VITROS 5600, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/61_22) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-61_22 FSN [PDF, 130 KB] (opens in new tab)
21 Dec 2015	Allura Xper FD20 X-Ray Imaging System, Philips Medical Systems Nederland BV (HSA 600:41/01-026/15/42_55) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-15-42_55 FSN [PDF, 131 KB] (opens in new tab)
18 Dec 2015	Datascope Cardiosave™ Intra-Aortic Balloon Pump, Datascope Corp (HSA 600:41/01-017/15/12_54) Local Contact: IDS Medical Systems (Singapore) Pte Ltd Contact no./Email: kennethow@idsmed.com	HSA 6004101-017-15-12_54 FSN [PDF, 146 KB] (opens in new tab)
17 Dec 2015	neXtra® Cutter Shaver Blades, DePuy Mitek (HSA 600:41/01-002/15/59_41) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276459	HSA 6004101-002-15-59_41 FSN [PDF, 51 KB] (opens in new tab)
17 Dec 2015	Certofix Quattro, B Braun Melsungen AG (HSA 600:41/01-012/15/10_51) Local Contact: B Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-15-10_51 FSN [PDF, 47 KB] (opens in new tab)
17 Dec 2015	Titanium Fluted Stem Extender, Howmedica Osteonics Corp (HSA 600:41/01-014/15/14_45) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: 65009507	HSA 6004101-014-15-14_45 FSN [PDF, 64 KB] (opens in new tab)
17 Dec 2015	Dengue NS1 Ag Strip, Bio-Rad Laboratories (HSA 600:41/01-027/15/05_20) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: jenny_tok@bio-rad.com	HSA 6004101-027-15-05_20 FSN [PDF, 56 KB] (opens in new tab)
17 Dec 2015	Oxylog 3000, 3000 plus & 2000 plus, Draegerwerk AG & Co KGaA (HSA 600:41/01-063/15/05_52) Local Contact: Draeger Medical SEA Pte Ltd Contact no./Email: Dsa.singapore@draeger.com	HSA 6004101-063-15-05_52 FSN [PDF, 1714 KB] (opens in new tab)
16 Dec 2015	ArmeoPower, Hocoma AG (HSA 600:41/01-286/15/01_35) Local Contact: Hocoma Pte Ltd Contact no./Email: 65130580	HSA 6004101-286-15-01_35 FSN [PDF, 136 KB] (opens in new tab) HSA 6004101-286-15-01_35 FSN [PDF, 129 KB] (opens in new tab) HSA 6004101-286-15-01_35 FSN [PDF, 129 KB] (opens in new tab) HSA 6004101-286-15-01_35 FSN [PDF, 134 KB] (opens in new tab)
16 Dec 2015	Perseus A500 Anesthesia Workstation, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/15/04_40) Local Contact: Draeger Medical SEA Pte Ltd Contact no./Email: 68729288	HSA 6004101-063-15-04_40 FSN [PDF, 2349 KB] (opens in new tab)
16 Dec 2015	Magnetom MR Systems and Biograph mMR, Siemens AG (for all MR systems except Magnetom Essenza); Siemens Shenzhen Magnetic Resonance Ltd (for Magnetom Essenza) (HSA 600:41/01-022/15/63_37) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-63_37 FSN [PDF, 340 KB] (opens in new tab)
16 Dec 2015	Discovery MR750w; Discovery MR750, GE Medical Systems LLC (HSA 600:41/01-010/15/22_36) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668	HSA 6004101-010-15-22_36 FSN [PDF, 243 KB] (opens in new tab)
16 Dec 2015	PFNA, PFNA-II, DFN, & PFN Nails, PFNA & PFNA-II Blades, and PFNA & PFNA-II End Cap Extensions, Synthes GmbH (HSA 600:41/01-002/15/58_49) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-58_49 FSN [PDF, 85 KB] (opens in new tab)
15 Dec 2015	Samarys Peek Anterior Cervical Cage, Scient'x SAS (HSA 600:41/01-198/15/01_33) Local Contact: Scient’x Asia Pacific Pte Ltd Contact no./Email: 64669460	HSA 6004101-198-15-01_33 FSN [PDF, 280 KB] (opens in new tab)
14 Dec 2015	Osteo-Site® Murphy Side Bevel Bone Biopsy Needle Set, Cook Incorporated(HSA 600:41/01-013/15/07_54) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 62877888	HSA 6004101-013-15-07_54 FSN [PDF, 28 KB] (opens in new tab)
14 Dec 2015	EchoTip® Ultra Endobronchial High Definition Ultrasound Needles, Cook Ireland Ltd (HSA 600:41/01-013/15/08_46) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 62877888	HSA 6004101-013-15-08_46 FSN [PDF, 59 KB] (opens in new tab)
14 Dec 2015	Soluscope Serie 4 PA, Soluscope SAS (HSA 600:41/01-017/15/10_56) Local Contact: IDS Medical Systems (Singapore) Pte Ltd Contact no./Email: kennethow@idsmed.com	HSA 6004101-017-15-10_56 FSN [PDF, 158 KB] (opens in new tab)
14 Dec 2015	Maquet FLOW-i Anesthesia System, Maquet Critical Care AB (HSA 600:41/01-017/15/11_29) Local Contact: IDS Medical Systems (Singapore) Pte Ltd Contact no./Email: kennethow@idsmed.com	HSA 6004101-017-15-11_29 FSN [PDF, 28 KB] (opens in new tab)
14 Dec 2015	Ambu AurGain Single Use Laryngeal Mask, Ambu A/S (HSA 600:41/01-056/15/03_45) Local Contact: Gold Lite Pte Ltd Contact no./Email: 62730487	HSA 6004101-056-15-03_45 FSN [PDF, 387 KB] (opens in new tab)
14 Dec 2015	Source Administration Sets (SAS), Bayer Medical Care (HSA 600:41/01-069/15/02_55) Local Contact: O'Connor's Singapore Pte Ltd Contact no./Email: 64737944	HSA 6004101-069-15-02_55 FSN [PDF, 465 KB] (opens in new tab)
14 Dec 2015	Arcadophta ® ARCOTANE C8F18 Purified Perfluoro-n-octane for Retinal Surgery, Arcadophta (HSA 600:41/01-104/15/01_18) Local Contact: SurgiPro Pte Ltd Contact no./Email: 68946038	HSA 6004101-104-15-01_18 FSN [PDF, 3833 KB] (opens in new tab)
14 Dec 2015	GlideScope Reusable GVL and AVL Blades, Verathon Medical Inc (HSA 600:41/01-076/16/03_43) Local Contact: Radiance Medical Systems Contact no./Email: 63162712	HSA 6004101-076-16-03_43 FSN [PDF, 189 KB] (opens in new tab)
10 Dec 2015	Synthes SynReam Medullary Reamer Head 13.5mm, Mathys Medical Ltd (HSA 600:41/01-002/15/57_53) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276459	HSA 6004101-002-15-57_53 FSN [PDF, 2574 KB] (opens in new tab)
08 Dec 2015	Terumo® Destination® Renal Guiding Sheath, Terumo Medical Corporation (HSA 600:41/01-028/15/01_44) Local Contact: Terumo Medical Corporation Contact no./Email: 62913603	HSA 6004101-028-15-01_44 FSN [PDF, 80 KB] (opens in new tab)
08 Dec 2015	da Vinci Xi Endoscope with Camera, 8mm, 0 deg and 30 deg, Intuitive Surgical (HSA 600:41/01-070/15/22_52) Local Contact: Transmedic Pte Ltd Contact no./Email: 64776101	HSA 6004101-070-15-22_52 FSN [PDF, 151 KB] (opens in new tab)
07 Dec 2015	Beckman Coulter Unicel DxH 600 and 800 Coulter Cellular Analysis System, Beckman Coulter Inc. (HSA 600:41/01-052/15/11_61)\| Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 63407126	HSA 6004101-052-15-11_61 FSN [PDF, 1433 KB] (opens in new tab)
07 Dec 2015	PuraStat, 3-D Matrix Europe SAS (HSA 600:41/01-282/15/02_51) Local Contact: 3-D Matrix Asia Pte Ltd Contact no./Email: 64083858	HSA 6004101-282-15-02_51 FSN [PDF, 138 KB] (opens in new tab)
07 Dec 2015	Absorb Bioresorbable Vascular Scaffold System and Absorb GT1 Bioresorbable Vascular Scaffold System, Abbott Vascular (HSA 600:41/01-005/15/06_43) Local Contact: Abbott Laboratories (S) Pte Ltd Contact no./Email: FSN_Inquiry@abbott.com	HSA 6004101-005-15-06_43 FSN [PDF, 134 KB] (opens in new tab)
07 Dec 2015	Endo GIA Ultra Universal Stapler Handles, Covidien llc (HSA 600:41/01-046/15/09_41) Local Contact: Covidien Private Limited Contact no./Email: 64396974	HSA 6004101-046-15-09_41 FSN [PDF, 1849 KB] (opens in new tab)
07 Dec 2015	Masimo Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet, Masimo Corporation (HSA 600:41/01-061/15/01_50) Local Contact: Masimo Asia Pacific Pte Ltd Contact no./Email: 65216700	HSA 6004101-061-15-01_50 FSN [PDF, 9052 KB] (opens in new tab)
04 Dec 2015	PFN/PFNA Insertion Handle, Synthes GmbH (HSA 600:41/01-002/15/55_49) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 65-68276135	HSA 6004101-002-15-55_49 FSN [PDF, 117 KB] (opens in new tab)
04 Dec 2015	ADVIA 1200/1800/2400 Chemistry Systems, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/15/62_60) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-62_60 FSN [PDF, 103 KB] (opens in new tab)
04 Dec 2015	Kirschner Wire 1.6mm w/Drill Tip, L 200mm, sterile, Synthes GmbH (HSA 600:41/01-002/15/56_36) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 65-68276135	HSA 6004101-002-15-56_36 FSN [PDF, 76 KB] (opens in new tab)
03 Dec 2015	GYNECARE THERMACHOICE™ III Thermal Balloon Ablation Silicone Catheter, Ethicon, Inc. (HSA 600:41/01-002/15/54_33) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 65-68276135	HSA 6004101-002-15-54_33 FSN [PDF, 462 KB] (opens in new tab)
03 Dec 2015	Cellistypt, Cellistypt D-K and Cellistypt F, Synthesia, a.s. (HSA 600:41/01-012/15/09_37) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-15-09_37 FSN [PDF, 235 KB] (opens in new tab)
02 Dec 2015	Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT SP, Brilliance iCT, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/15/41_19) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-15-41_19 FSN [PDF, 109 KB] (opens in new tab)
02 Dec 2015	Olympus Endoeye HD II, Olympus Winter & Ibe GmbH (HSA 600:41/01-004/15/07_29) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: 68334219	HSA 6004101-004-15-07_29 FSN [PDF, 358 KB] (opens in new tab)
01 Dec 2015	Cytoluer Set, Baxter Healthcare SA, (HSA 600:41/01-001/15/04_25) Local Contact: Baxter Healthcare (Asia) Pte Ltd Contact no./Email: 65-68262616	HSA 6004101-001-15-04_25 FSN [PDF, 79 KB] (opens in new tab)
01 Dec 2015	Bond Polymer Refine Red Detection, Leica Biosystems Newcastle Ltd (HSA 600:41/01-126/15/05_59) Local Contact: Leica Microsystems (SEA) Pte Ltd Contact no./Email: 65505975	HSA 6004101-126-15-05_59 FSN [PDF, 1751 KB] (opens in new tab)