Field Safety Notices

Field Safety Notice - Aug 2016

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 August 2016

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Table caption

DATE OF NOTIFICATION	TITLE	FSN
31 Aug 2016	TANDEM™ BIPOLAR HIP SYSTEM, Smith & Nephew Inc (HSA 600:41/01-073/16/24_52) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-24_52 FSN [PDF, 105 KB] (opens in new tab)
31 Aug 2016	IMMULITE®, IMMULITE® 1000/ 2000/ 2000 Xpi, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/42_60) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-42_60 FSN [PDF, 102 KB] (opens in new tab)
31 Aug 2016	Intraocular Lenses, Abbott Medical Optics, Inc (HSA 600:41/01-018/16/01_63) Local Contact: AMO Singapore Pte Ltd Contact no./Email: 68448833	HSA 6004101-018-16-01_63 FSN [PDF, 252 KB] (opens in new tab)
30 Aug 2016	Philips Brilliance 64 and Ingenuity CT/Core/Core 128, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/31_50) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-31_50 FSN [PDF, 127 KB] (opens in new tab)
29 Aug 2016	Muller Hinton 2 agar + 5% sheep blood, BioMérieux SA (HSA 600:41/01-146/16/09_58) Local Contact: Biomerieux Singapore Pte Ltd Contact no./Email: 68016706	HSA 6004101-146-16-09_58 FSN [PDF, 325 KB] (opens in new tab)
25 Aug 2016	Thermo Scientific Oxoid CT1629B CAZ10 CEFTAZIDIME, Oxoid Limited (HSA 600:41/01-178/16/06_57) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: customerservice.mbdsingapore@thermofisher.com	HSA 6004101-178-16-06_57 FSN [PDF, 125 KB] (opens in new tab)
25 Aug 2016	EnCor® Needle Guide Insert 10G, SenoRx, Inc (HSA 600:41/01-050/16/05_36) Local Contact: Bard Singapore Pte Ltd Contact no./Email: complaints.singapore@crbard.com	HSA 6004101-050-16-05_36 FSN [PDF, 97 KB] (opens in new tab)
25 Aug 2016	ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c), Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/41_38) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-41_38 FSN [PDF, 90 KB] (opens in new tab)
25 Aug 2016	OPTILENE 4/0 (1,5) 90CM 2XHRC22, B. Braun Surgical SA (HSA 600:41/01-012/16/08_44) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-16-08_44 FSN [PDF, 136 KB] (opens in new tab)
25 Aug 2016	SIGNA Creator and SIGNA Explorer, GE Healthcare (Tianjin) Company Limited (HSA 600:41/01-010/16/13_40) Local Contact: GE Healthcare Pte Ltd Contact no./Email: scv@ge.com	HSA 6004101-010-16-13_40 FSN [PDF, 282 KB] (opens in new tab)
25 Aug 2016	BD Vacutainer® Push Button Blood Collection Set, Becton, Dickinson and Company (HSA 600:41/01-003/16/08_49) Local Contact: Becton Dickinson Holdings Pte Ltd (BD) Contact no./Email: 64322048	HSA 6004101-003-16-08_49 FSN [PDF, 248 KB] (opens in new tab)
24 Aug 2016	Sagittal Blade 18.0X.97X90MM, Stryker Instruments (HSA 600:41/01-014/16/11_35) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com	HSA 6004101-014-16-11_35 FSN [PDF, 90 KB] (opens in new tab)
24 Aug 2016	Bio-Rad EVOLIS Systems, DiaMed GmbH (HSA 600:41/01-027/16/10_07) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262	HSA 6004101-027-16-10_07 FSN [PDF, 440 KB] (opens in new tab)
23 Aug 2016	Infant Warmer System, Ohmeda Medical (HSA 600:41/01-010/16/12_37) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-12_37 FSN [PDF, 1041 KB] (opens in new tab)
23 Aug 2016	Misago Self-Expanding Stent System, Terumo Corporation (HSA 600:41/01-028/16/05_33) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 62913603	HSA 6004101-028-16-05_33 FSN [PDF, 67 KB] (opens in new tab)
22 Aug 2016	Trident Universal Impactor/Positioner, Howmedica Osteonics Corp (HSA 600:41/01-014/16/10_45) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com	HSA 6004101-014-16-10_45 FSN [PDF, 163 KB] (opens in new tab)
22 Aug 2016	Hermann Gastronomy Dressing Set, Fresenius Kabi AG (HSA 600:41/01-020/16/01_19) Local Contact: Fresenius Kabi (Singapore) Pte Ltd Contact no./Email: 68372552	HSA 6004101-020-16-01_19 FSN [PDF, 27 KB] (opens in new tab)
22 Aug 2016	UniCel DxH 800 & DxH 600 Coulter Cellular Analysis System, Beckman Coulter Inc. (HSA 600:41/01-052/16/11_61) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 63407126	HSA 6004101-052-16-11_61 FSN [PDF, 75 KB] (opens in new tab)
22 Aug 2016	Waismed NIO Adult Intraosseous Device, WaisMed Limited (HSA 600:41/01-301/16/01_25) Local Contact: EO Medical Pte Ltd Contact no./Email: 61005060	HSA 6004101-301-16-01_25 FSN [PDF, 3045 KB] (opens in new tab)
19 Aug 2016	Roadrunner® UniGlide® Hydrophilic Wire Guide, Cook Incorporated (HSA 600:41/01-013/16/04_18) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 68127400	HSA 6004101-013-16-04_18 FSN [PDF, 134 KB] (opens in new tab)
19 Aug 2016	ATEC Canister used with ATEC vacuum-assisted breast biopsy systems, Hologic, Inc, (HSA 600:41/01-196/16/01_51) Local Contact: Medical Imaging Systems Pte Ltd Contact no./Email: 94359898	HSA 6004101-196-16-01_51 FSN [PDF, 73 KB] (opens in new tab)
18 Aug 2016	Syva Emit II Plus Opiate / Dimension Opiates / ADVIA Chemistry Opiate_2 Assays, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/40_59) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-40_59 FSN [PDF, 90 KB] (opens in new tab) HSA 6004101-022-16-40_59 FSN [PDF, 90 KB] (opens in new tab) HSA 6004101-022-16-40_59 FSN [PDF, 90 KB] (opens in new tab)
18 Aug 2016	Lyphochek Coagulation Control, Bio-Rad Laboratories Diagnostics Group (HSA 600:41/01-027/16/09_60) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262	HSA 6004101-027-16-09_60 FSN [PDF, 171 KB] (opens in new tab)
17 Aug 2016	HYDRO LeMaitre Valvulotome, LeMaitre Vascular, Inc (HSA 600:41/01-057/16/04_09) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: info@somnotec.net	HSA 6004101-057-16-04_09 FSN [PDF, 467 KB] (opens in new tab)
17 Aug 2016	Snowden-Pencer Diamond-Flex Circular Retractor, Angled, 40mm, 5mm, Carefusion (HSA 600:41/01-145/16/01_56) Local Contact: Medquest Marketing Pte Ltd Contact no./Email: 68051250	HSA 6004101-145-16-01_56 FSN [PDF, 4096 KB] (opens in new tab)
16 Aug 2016	Fluorocell PLT, Sysmex Corporation (HSA 600:41/01-032/16/05_57) Local Contact: Sysmex Asia Pacific Pte Ltd Contact no./Email: 6221 3629 / RA@sysmex-ap.com	HSA 6004101-032-16-05_57 FSN [PDF, 1084 KB] (opens in new tab)
16 Aug 2016	Blue Ortho Exactech® GPS System – GPS Station V2, Blue Ortho (HSA 600:41/01-257/16/02_48) Local Contact: Exactech Pte Ltd Contact no./Email: 6273 0091	HSA 6004101-257-16-02_48 FSN [PDF, 264 KB] (opens in new tab)
16 Aug 2016	VITROS Chemistry Products GLU/LAC/TRIG/URIC slides, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/34_58 ) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: bsee@its.jnj.com	HSA 6004101-002-16-34_58 FSN [PDF, 136 KB] (opens in new tab)
16 Aug 2016	RAPIDPoint® 400/405/500 Systems, RAPIDLab® 1200 Systems IPOC 16-0211, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/16/39_57) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-39_57 FSN [PDF, 22 KB] (opens in new tab)
15 Aug 2016	IS4000 EndoWrist Stapler 45, Intuitive Surgical, Inc. (HSA 600:41/01-070/16/18_41) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com	HSA 6004101-070-16-18_41 FSN [PDF, 451 KB] (opens in new tab)
15 Aug 2016	Astral 100 and Astral 150, ResMed Ltd (HSA 600:41/01-275/16/01_54) Local Contact: RESMED ASIA OPERATIONS PTY LIMITED (SINGAPORE BRANCH) Contact no./Email: 6572 5936	HSA 6004101-275-16-01_54 FSN [PDF, 241 KB] (opens in new tab)
15 Aug 2016	LIFEPAK CR Plus/ LIFEPAK EXPRESS Automatic External Defibrillator(s), PHYSIO-CONTROL, INC. (HSA 600:41/01-056/16/06_49) Local Contact: Gold Lite Pte Ltd Contact no./Email: 6273 0487	HSA 6004101-056-16-06_49 FSN [PDF, 28 KB] (opens in new tab)
15 Aug 2016	YSIO, YSIO MAX, MULTIX FUSION, Siemens Healthcare GmbH (HSA 600:41/01-022/16/38_44) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-38_44 FSN [PDF, 1631 KB] (opens in new tab)
15 Aug 2016	Merge Eye Care PACS, Merge Healthcare Incorporated (HSA 600:41/01-110/16/03_36) Local Contact: Mandarin Opto-Medic Co Pte Ltd Contact no./Email: manopt@mandarinoptomedic.com	HSA 6004101-110-16-03_36 FSN [PDF, 642 KB] (opens in new tab)
15 Aug 2016	Merge Eye Station and Eye Care PACS, Merge Healthcare Incorporated (HSA 600:41/01-110/16/02_35) Local Contact: Mandarin Opto-Medic Co Pte Ltd Contact no./Email: manopt@mandarinoptomedic.com	HSA 6004101-110-16-02_35 FSN [PDF, 716 KB] (opens in new tab)
15 Aug 2016	UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Beckman Coulter Inc. (HSA 600:41/01-052/16/10_34) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: khwong@beckman.com	HSA 6004101-052-16-10_34 FSN [PDF, 75 KB] (opens in new tab)
15 Aug 2016	STIMPOD NMS410 / NMS450 Nerve Stimulator, Xavant Technology (HSA 600:41/01-017/16/07_43) Local Contact: IDS Medical Systems (S) Pte Ltd Contact no./Email: kennethow@Idsmed.com	HSA 6004101-017-16-07_43 FSN [PDF, 327 KB] (opens in new tab)
15 Aug 2016	Molnlycke Caesarean Section Pack & Molnlcyke GEH C-Section Pack, Molnlycke Health Care AB (HSA 600:41/01-228/16/01_40) Local Contact: Molnlycke Health Care Asia-Pacific Pte Ltd Contact no./Email: suki.lim@molnlycke.com	HSA 6004101-228-16-01_40 FSN [PDF, 83 KB] (opens in new tab)
15 Aug 2016	AcrySof IQ IOL with ULTRASERT"' delivery system, Alcon Laboratories Inc. (HSA 600:41/01-135/16/04_46) Local Contact: Alcon Pte Ltd Contact no./Email: 6722 1255	HSA 6004101-135-16-04_46 FSN [PDF, 102 KB] (opens in new tab)
15 Aug 2016	QUANTUM BLUE CALPROTECTIN ASSAY, 25 tests, BUHLMANN Laboratories AG (HSA 600:41/01-137/16/01_38) Local Contact: All Eights (Singapore) Pte Ltd Contact no./Email: 6288 6388	HSA 6004101-137-16-01_38 FSN [PDF, 416 KB] (opens in new tab)
12 Aug 2016	Exactech Total Knee Arthroplasty Software Application, Blue Ortho (HSA 600:41/01-257/16/01_19) Local Contact: Exactech Pte Ltd Contact no./Email: 6273 0091	HSA 6004101-257-16-01_19 FSN [PDF, 263 KB] (opens in new tab) HSA 6004101-257-16-01_19 FSN [PDF, 220 KB] (opens in new tab)
12 Aug 2016	Symbia E systems, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/37_33) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-37_33 FSN [PDF, 6846 KB] (opens in new tab)
12 Aug 2016	Hill-Rom Progressa bed System with European (OIML), Hill-Rom Inc (HSA 600:41/01-182/16/01_25) Local Contact: Hill-Rom Services Private Limited Contact no./Email: huifang.zhu@hill-rom.com	HSA 6004101-182-16-01_25 FSN [PDF, 742 KB] (opens in new tab)
12 Aug 2016	ADVIA Centaur Systems Calibrator U, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/36_24) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-36_24 FSN [PDF, 171 KB] (opens in new tab)
11 Aug 2016	Spacelab Healthcare ULTRAVIEW SL ™ MONITOR SYSTEM, Spacelabs Healthcare, Inc (HSA 600:41/01-029/16/02_18) Local Contact: SpaceLabs Healthcare Pte Ltd Contact no./Email: 6853 6306	HSA 6004101-029-16-02_18 FSN [PDF, 44 KB] (opens in new tab)
8 Aug 2016	CADstream, Merge Healthcare (HSA 600:41/01-010/16/11_08) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-11_08 FSN [PDF, 489 KB] (opens in new tab)
8 Aug 2016	PRIMEDIC AkuPak LITE, METRAX GmbH (HSA 600:41/01-029/16/01_17) Local Contact: SpaceLabs Healthcare Pte Ltd Contact no./Email: steven.tan@spacelabs.com	HSA 6004101-029-16-01_17 FSN [PDF, 109 KB] (opens in new tab)
5 Aug 2016	Elekta MOSAIQ, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/06_09) Local Contact: Elekta Pte Ltd Contact no./Email: Elekta_Global_PMS@elekta.com	HSA 6004101-101-16-06_09 FSN [PDF, 54 KB] (opens in new tab)
4 Aug 2016	Ethicon Mersilene™ Tape, Ethicon Inc (HSA 600:41/01-002/16/33_56) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: bsee@its.jnj.com	HSA 6004101-002-16-33_56 FSN [PDF, 181 KB] (opens in new tab)
3 Aug 2016	Whipknot Soft Tissue Cinch #5 Sutures, Smith & Nephew Inc (HSA 600:41/01-073/16/23_48) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-23_48 FSN [PDF, 259 KB] (opens in new tab)
3 Aug 2016	Medtronic EnVeo R Delivery Catheter System, Medtronic CoreValve LLC (HSA 600:41/01-009/16/14_54) Local Contact: Medtronic International Limited Contact no./Email: shezhiyan@medtronic.com	HSA 6004101-009-16-14_54 FSN [PDF, 65 KB] (opens in new tab)
3 Aug 2016	CDX2, Dako Denmark A/S (HSA 600:41/01-086/16/01_23) Local Contact: SPD Scientific Pte Ltd Contact no./Email: Dako.dkvigilance@agilent.com	HSA 6004101-086-16-01_23 FSN [PDF, 19 KB] (opens in new tab)
3 Aug 2016	Etest Colistin CO 256 WW, bioMérieux SA (HSA 600:41/01-146/16/08_22) Local Contact: Biomerieux Singapore Pte Ltd Contact no./Email: 6801 6706	HSA 6004101-146-16-08_22 FSN [PDF, 401 KB] (opens in new tab)
3 Aug 2016	Macopharma Blood Bags with CPD and LCR Filters, MacoPharma (HSA 600:41/01-033/16/06_52) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: regulatory@biomed.com.sg	HSA 6004101-033-16-06_52 FSN [PDF, 316 KB] (opens in new tab)
2 Aug 2016	Lotus Valve System, Boston Scientific Corporation (HSA 600:41/01-007/16/05_63) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: Singapore_FSCA_Query@bsci.com	HSA 6004101-007-16-05_63 FSN [PDF, 3343 KB] (opens in new tab)
2 Aug 2016	da Vinci® Xi™ EndoWrist Stapler, Intuitive Surgical Inc. (HSA 600:41/01-070/16/17_51) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com	HSA 6004101-070-16-17_51 FSN [PDF, 467 KB] (opens in new tab)
2 Aug 2016	ImmunoCAP Specific IgE Control H lot CYYAC, Phadia AB (HSA 600:41/01-033/16/05_20) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: 65087663	HSA 6004101-033-16-05_20 FSN [PDF, 116 KB] (opens in new tab)
1 Aug 2016	ADVIA Centaur PSA, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/35_07) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-35_07 FSN [PDF, 33 KB] (opens in new tab)
1 Aug 2016	Philips IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, Philips Medizin Systeme Boblingen GmbH (HSA 600:41/01-026/16/30_41) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-16-30_41 FSN [PDF, 127 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) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999993	HSA 6004101-178-16-05_60 FSN [PDF, 176 KB] (opens in new tab)
26 Apr 2016	Cell Saver Elite disposable processing kits, Haemonetics Corporation (HSA 600:41/01-070/16/11_29) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com	HSA 6004101-070-16-11_29 FSN [PDF, 273 KB] (opens in new tab)
03 Dec 2015	HU35, HCU20, HCU30, HCU40 Systems, Maquet Cardiopulmonary AG (HSA 600:41/01-017/15/09_35) Local Contact: IDS Medical Systems (Singapore) Pte Ltd Contact no./Email: 66907380	HSA 6004101-017-15-09_35 FSN [PDF, 1320 KB] (opens in new tab)