Field Safety Notices

Field Safety Notice - Sep 2016

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 September 2016

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Table caption

DATE OF NOTIFICATION	TITLE	FSN
30 Sep 2016	Xpert HIV-1 Viral Load, Cepheid (HSA 600:41/01-086/16/02_38) Local Contact: SPD Scientific Pte Ltd Contact no./Email: 63039870	HSA 6004101-086-16-02_38 FSN [PDF, 146 KB] (opens in new tab)
30 Sep 2016	Restylane Lidocaine 1ml, Q-Med AB (HSA 600:41/01-230/16/01_35) Local Contact: Galderma Singapore Pte Ltd Contact no./Email: 68389359	HSA 6004101-230-16-01_35 FSN [PDF, 667 KB] (opens in new tab)
29 Sep 2016	Welch Allyn MS3 Connex Spot Classic Mobile Stand & Power Supply, Welch Allyn Inc (HSA 600:41/01-006/16/01_37) Local Contact: Welch Allyn Singapore Pte Ltd Contact no./Email: 68709165	HSA 6004101-006-16-01_37 FSN [PDF, 131 KB] (opens in new tab)
28 Sep 2016	ABL90 FLEX Analyzer, Radiometer Medical Aps (HSA 600:41/01-219/16/03_34) Local Contact: Radiometer S.E.A Pte Ltd Contact no./Email: 63896027	HSA 6004101-219-16-03_34 FSN [PDF, 63 KB] (opens in new tab)
26 Sep 2016	Tubeset Standard of Diego Elite System, Gyrus ACMI, Inc (HSA 600:41/01-004/16/04_18) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: mes-ra.osp@olympus-ap.com	HSA 6004101-004-16-04_18 FSN [PDF, 32 KB] (opens in new tab)
26 Sep 2016	PrimaryDiagnost Digital Systems, Philips India Limited (HSA 600:41/01-026/16/35_25) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-35_25 FSN [PDF, 695 KB] (opens in new tab)
23 Sep 2016	cobas c 111 analyzer & cobas c 111 analyzer with ISE, Roche Diagnostics GmbH (HSA 600:41/01-016/16/15_31) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-15_31 FSN [PDF, 663 KB] (opens in new tab)
23 Sep 2016	Sofradim Parietex Plug and Patch System, and ProGrip Self-Gripping Polyester Mesh, Sofradim Production (HSA 600:41/01-046/16/07_17) Local Contact: Covidien Private Limited Contact no./Email: 64396974	HSA 6004101-046-16-07_17 FSN [PDF, 494 KB] (opens in new tab)
22 Sep 2016	Philips Mobile Diagnost wDR 1 & 2, Philips Medical Systems (HSA 600:41/01-026/16/34_08) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-16-34_08 FSN [PDF, 203 KB] (opens in new tab)
21 Sep 2016	Instruments/Systems using rack trays, Roche Diagnostics GmbH (HSA 600:41/01-016/16/14_24) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-14_24 FSN [PDF, 825 KB] (opens in new tab)
21 Sep 2016	5.2mm Suction Punch, Smith & Nephew Inc., Endoscopy Division (HSA 600:41/01-073/16/25_09) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-25_09 FSN [PDF, 63 KB] (opens in new tab)
20 Sep 2016	GETINGE ED-FLOW AER & ED-FLOW SD AER, Getinge Lancer (HSA 600:41/01-224/16/01_64) Local Contact: Getinge Singapore Contact no./Email: 63967298	HSA 6004101-224-16-01_64 FSN [PDF, 461 KB] (opens in new tab)
19 Sep 2016	BD Hypodermic Syringes with Needles, Becton, Dickinson and Company (HSA 600:41/01-003/16/09_46) Local Contact: Becton Dickinson Holdings Pte Ltd (BD) Contact no./Email: 64322060	HSA 6004101-003-16-09_46 FSN [PDF, 56 KB] (opens in new tab)
19 Sep 2016	Philips IntelliVue MX40 Patient Wearable Monitor, Philips Medical Systems (HSA 600:41/01-026/16/32_43) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-16-32_43 FSN [PDF, 280 KB] (opens in new tab)
19 Sep 2016	Philips BV 25, BV300, BV ENDURA, BV PULSERA & BV LIBRA X-ray Systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/16/33_54) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-16-33_54 FSN [PDF, 207 KB] (opens in new tab)
16 Sep 2016	SPINOCATH G24/G29, SPINOCATH G22/G27, B. Braun Melsungen AG (HSA 600:41/01-012/16/09_50) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: press.sg@bbraun.com	HSA 6004101-012-16-09_50_FSN [PDF, 144 KB] (opens in new tab)
15 Sep 2016	RayStation (InverseArc 1.0), RaySearch Laboratories AB (HSA 600:41/01-070/16/19_40) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com	HSA 6004101-070-16-19_40 FSN [PDF, 629 KB] (opens in new tab)
14 Sep 2016	Dimension IRON, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/45_23) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-45_23 FSN [PDF, 91 KB] (opens in new tab)
13 Sep 2016	RAPIDPoint® 400/405 Measurement Cartridge Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/44_22) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-44_22 FSN [PDF, 17 KB] (opens in new tab)
8 Sept 2016	IMMULITE 1000, 2000, RUBELLA IGM, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/43_65) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-43_65 FSN [PDF, 103 KB] (opens in new tab)
8 Sept 2016	Esaote MyLab Twice, Esaote S.p.a. (HSA 600:41/01-288/16/01_17) Local Contact: Medical Plus Pte Ltd Contact no./Email: admin@medicalplus-group.com	HSA 6004101-288-16-01_17 FSN [PDF, 792 KB] (opens in new tab)
8 Sept 2016	Viva CRT-D and Evera ICD, Medtronic Inc (HSA 600:41/01-009/16/15_45) Local Contact: Medtronic International Limited Contact no./Email: 64365077	HSA 6004101-009-16-15_45 FSN [PDF, 328 KB] (opens in new tab)
8 Sept 2016	OSSEOTITE Certain Implant 4 x 11.5mm, Biomet 3i (HSA 600:41/01-181/16/02_25) Local Contact: Asia Implant Support & Services Contact no./Email: 6223 2229	HSA 6004101-181-16-02_25 FSN [PDF, 300 KB] (opens in new tab)
5 Sept 2016	Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/07_08) Local Contact: Elekta Pte Ltd Contact no./Email: 6221 2322	HSA 6004101-101-16-07_08 FSN [PDF, 54 KB] (opens in new tab)
2 Sept 2016	XR 6000, GE Hualun Medical Systems Co Ltd (HSA 600:41/01-010/16/15_09) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-15_09 FSN [PDF, 330 KB] (opens in new tab)
2 Sept 2016	Concept Heatwave Electrode, 130mm x 2.3mm diameter, Conmed Corporation (HSA 600:41/01-302/16/01_56) Local Contact: ConMed Singapore Pte Ltd Contact no./Email: 6255 4868	HSA 6004101-302-16-01_56 FSN [PDF, 85 KB] (opens in new tab)
1 Sept 2016	LFITTM Anatomic CoCr V40TM Femoral Heads, Howmedica Osteonics Corp (HSA 600:41/01-014/16/12_46) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com	HSA 6004101-014-16-12_46 FSN_Updated [PDF, 777 KB] (opens in new tab)
1 Sept 2016	MAGIC (MAGnetic resonance image Compilation) on Signa Pioneer and systems running application software version DV25.1, GE MEDICAL SYSTEMS, LLC (HSA 600:41/01-010/16/14_54) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-14_54 FSN [PDF, 280 KB] (opens in new tab)
26 Feb 2016	BD SurePath Preservative Collection Vial, BD Life Sciences (HSA 600/41:01-003/16/01_61) Local Contact: Becton Dickinson Holdings Pte Ltd (BD) Contact no./Email: 64322048	HSA 6004101-003-16-01_61 FSN [PDF, 232 KB] (opens in new tab)