Field Safety Notices

Field Safety Notice - Nov 2016

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 November 2016

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Table caption

DATE OF NOTIFICATION	TITLE	FSN
29 Nov 2016	ALARIS SYSTEM PC UNIT MODELS 8000 and 8015, CareFusion 303 Inc (HSA 600:41/01-003/16/10_35) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 64322048	HSA 6004101-003-16-10_35 FSN [PDF, 63 KB] (opens in new tab)
25 Nov 2016	AK98 Dialysis Machine, Gambro Lundai AB (HSA 600:41/01-001/16/05_37) Local Contact: Baxter Healthcare (Asia) Pte Ltd Contact no./Email: 68262616	HSA 6004101-001-16-05_37 FSN [PDF, 72 KB] (opens in new tab)
25 Nov 2016	Roche Diagnostics cobas b 123 POC system, Roche Diagnostics GmbH (HSA 600:41/01-016/16/19_34) Local Contact: Roche Diagnostics Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-19_34 FSN [PDF, 576 KB] (opens in new tab)
25 Nov 2016	NucliSENS® easyMAG®, NucliSENS® miniMAG® and eMAG, bioMérieux SA (HSA 600:41/01-146/16/10_57) Local Contact: Biomerieux Singapore Pte Ltd Contact no./Email: 68016706	HSA 6004101-146-16-10_57 FSN [PDF, 375 KB] (opens in new tab)
24 Nov 2016	SEQUENT PLEASE 2.0X20MM, B. Braun Melsungen AG (HSA 600:41/01-012/16/11_19) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130943	HSA 6004101-012-16-11_19 FSN [PDF, 815 KB] (opens in new tab)
24 Nov 2016	IMMULITE® 2000/ IMMULITE® 2000 XPi Intact PTH, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/52_22) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-52_22 FSN [PDF, 83 KB] (opens in new tab)
24 Nov 2016	Straumann Dental Surgical Instruments, Institut Straumann AG (HSA 600:41/01-260/16/01_45) Local Contact: Implant Focus Contact no./Email: 67415411	HSA 6004101-260-16-01_45 FSN [PDF, 111 KB] (opens in new tab)
24 Nov 2016	QUINN'S ADVANTAGE MEDIUM WITH HEPES, Cooper Surgical Inc (HSA 600:41/01-262/16/01_25) Local Contact: Neuvital Pte Ltd Contact no./Email: 62766088	HSA 6004101-262-16-01_25 FSN [PDF, 388 KB] (opens in new tab)
24 Nov 2016	Ortho Vision Analyser and Ortho Vision Max Analyser for Ortho BioVue Cassettes, Ortho Clinical Diagnostics Inc (HSA 600:41/01-303/16/05_31) Local Contact: Ortho Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 64861151	HSA 6004101-303-16-05_31 FSN [PDF, 503 KB] (opens in new tab)
24 Nov 2016	IMMULITE/ IMMULITE 1000/ 2000/ 2000 XPi PSA, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/53_24) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-53_24 FSN [PDF, 92 KB] (opens in new tab)
23 Nov 2016	Bio-Rad TPHA 200, Lab21 Healthcare Limited (HSA 600:41/01-027/16/13_65) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262	HSA 6004101-027-16-13_65 FSN [PDF, 153 KB] (opens in new tab) HSA 6004101-027-16-13_65 FSN [PDF, 73 KB] (opens in new tab)
23 Nov 2016	GE Healthcare MRI systems, GE Medical Systems, LLC (HSA 600:41/01-010/16/21_18) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-21_18 FSN [PDF, 371 KB] (opens in new tab)
22 Nov 2016	Weck Visistat Skin Stapler, Teleflex Medical (HSA 600:41/01-139/16/08_08) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 64390000	HSA 6004101-139-16-08_08 FSN [PDF, 181 KB] (opens in new tab)
21 Nov 2016	Reflection Dead Blow Mallet, Smith & Nephew Inc (HSA 600:41/01-073/16/28_64) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-28_64 FSN [PDF, 81 KB] (opens in new tab)
21 Nov 2016	JMS Infusion Set T200 W/21G, JMS Singapore Pte Ltd (HSA 600:41/01-306/16/01_09) Local Contact: JMS Singapore Pte Ltd Contact no./Email: sales@jmss.com.sg	HSA 6004101-306-16-01_09 FSN [PDF, 163 KB] (opens in new tab)
16 Nov 2016	ARCHITECT Toxo IgM, Abbott GmbH & Co. KG (HSA 600:41/01-005/16/11_61) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: FSN_enquiry@abbott.com	HSA 6004101-005-16-11_61_FSN [PDF, 73 KB] (opens in new tab)
16 Nov 2016	Lateral Shoulder Connection Bar, Smith & Nephew Inc (HSA 600:41/01-073/16/27_56) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-27_56 FSN [PDF, 62 KB] (opens in new tab)
10 Nov 2016	Arrow OnControl Bone Marrow Biopsy System, Aspiration System and Bone Lesion Biopsy System, Teleflex Medical (HSA 600:41/01-139/16/07_48) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 64393000	HSA 6004101-139-16-07_48 FSN [PDF, 298 KB] (opens in new tab)
09 Nov 2016	Source Administration Sets with Medrad Intego PET Infusion System, Bayer Medical Care (HSA 600:41/01-069/16/01_46) Local Contact: O'Connor's Singapore Pte Ltd Contact no./Email: enquiries@oconnors.wbl.com.sg	HSA 6004101-069-16-01_46 FSN [PDF, 67 KB] (opens in new tab)
8 Nov 2016	Surefuser+, Nipro Corporation (HSA 600:41/01-233/16/03_52) Local Contact: Nipro Asia Pte Ltd Contact no./Email: 6588 2281	HSA 6004101-233-16-03_52 FSN [PDF, 1108 KB] (opens in new tab)
7 Nov 2016	GAM Kirschner Wire, T2 K-Wire, T2 K-Wire Recon, Stryker Trauma GmbH (HSA 600:41/01-014/16/15_63) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: asean.pms@stryker.com	HSA 6004101-014-16-15_63 FSN [PDF, 333 KB] (opens in new tab)
4 Nov 2016	Ortho Reagent Red Blood Cell (RRBC) products, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/04_60) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 6486 1151	HSA 6004101-303-16-04_60 FSN [PDF, 572 KB] (opens in new tab)
4 Nov 2016	Lullaby Warmer, Wipro GE Healthcare Private Ltd (HSA 600:41/01-010/16/20_51) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-20_51 FSN [PDF, 485 KB] (opens in new tab)
4 Nov 2016	Medtronic O-arm™ O2 Imaging System, Medtronic Navigation, Inc (Littleton) (HSA 600:41/01-009/16/17_50) Local Contact: Medtronic International Limited Contact no./Email: 6436 5000	HSA 6004101-009-16-17_50 FSN [PDF, 36 KB] (opens in new tab)
3 Nov 2016	LMA Mucosal Atomization Devices, Wolf Tory Medical, Inc (HSA 600:41/01-139/16/06_41) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 64393000	HSA 6004101-139-16-06_41 FSN [PDF, 165 KB] (opens in new tab)
3 Nov 2016	Orthomatch quick connect handle, Smith & Nephew Inc (HSA 600:41/01-073/16/26_40) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-26_40 FSN [PDF, 59 KB] (opens in new tab)
3 Nov 2016	Defibrillation electrode Schiller 0-21-0040 & 2.155065, Schiller Medical S.A.S (HSA 600:41/01-056/16/07_36) Local Contact: Gold Lite Pte Ltd Contact no./Email: 62730487	HSA 6004101-056-16-07_36 FSN [PDF, 2400 KB] (opens in new tab)
3 Nov 2016	Exactech Equinoxe Reverse Shoulder System -Fixed Angle Torque Defining Screw Kit, Exactech Inc (HSA 600:41/01-257/16/03_44) Local Contact: Exactech Pte Ltd Contact no./Email: 6273 0091	HSA 6004101-257-16-03_44 FSN [PDF, 206 KB] (opens in new tab)
2 Nov 2016	RPR kit, Bio-Rad France (HSA 600:41/01-027/16/12_59) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 6490 4262	HSA 6004101-027-16-12_59 FSN [PDF, 65 KB] (opens in new tab)
2 Nov 2016	Lullaby Led Phototherapy System, Wipro GE Healthcare Private Ltd (HSA 600:41/01-010/16/19_49) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-19_49 FSN [PDF, 62 KB] (opens in new tab)
1 Nov 2016	Nellix EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V (HSA 600:41/01-148/16/02_54) Local Contact: DKSH Singapore Pte Ltd Contact no./Email: hec-ra.Sin@dksh.com	HSA 6004101-148-16-02_54 FSN [PDF, 366 KB] (opens in new tab)
1 Nov 2016	Innova X100, GE Medical Systems SCS (HSA 600:41/01-010/16/17_37) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-17_37 FSN [PDF, 439 KB] (opens in new tab)
1 Nov 2016	Avance, Avance CS2 and Amingo, Datex-Ohmeda, Inc. (HSA 600:41/01-010/16/18_35) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-18_35 FSN [PDF, 323 KB] (opens in new tab)
1 Nov 2016	Beckman Coulter Access Ostase, Beckman Coulter Inc. (HSA 600:41/01-052/16/12_58) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: khwong@beckman.com	HSA 6004101-052-16-12_58 FSN [PDF, 75 KB] (opens in new tab)
13 Oct 2016	Ortho-Clinical VITROS Immunodiagnostic Products Intact PTH Reagent Pack, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/01_65) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 64861151	HSA 6004101-303-16-01_65_FSN_ [PDF, 1393 KB] (opens in new tab)
28 Mar 2016	DiaMed Diaclon Anti-N, DiaMed GmbH (HSA 600:41/01-027/16/03_22) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262	HSA 6004101-027-16-03_22 FSN [PDF, 81 KB] (opens in new tab)