Field Safety Notices

Field Safety Notice - Jun 2019

30 June 2019

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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

Table caption

Date of Notification	Title	FSN
28 Jun 2019	Philips Ingenuity CT system, Philips Ingenuity TF PET/CT Imaging System, Philips Brilliance Computed Tomography X-Ray System, Philips IQon Spectral CT System, Philips Vereos PET/CT System, Philips Medical Systems(Cleveland), Inc (HSA 600:41/01-026/19/20_50) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-19-20_50 FSN [PDF, 998 KB] (opens in new tab)
28 Jun 2019	DATASCOPE INTRA-AORTIC BALLOON PUMPS (IABP), Datascope Corp. (HSA 600:41/01-224/19/07_80) Local Contact: Getinge South East Asia Pte Ltd Contact no./Email: 6296 1992	HSA 6004101-224-19-07_80 FSN [PDF, 650 KB] (opens in new tab)
28 Jun 2019	Somatom Force, Somatom Definition AS, Somatom Definition Edge, Somatom Definition Flash, Somatom Drive, Somatom Confidence, Somatom, Edge Plus, Siemens Healthcare GmbH (HSA 600:41/01-022/19/13_77) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-19-13_77 FSN [PDF, 1632 KB] (opens in new tab)
27 Jun 2019	MiniMed™ Paradigm™ Series Insulin Pumps, Medtronic MiniMed (HSA 600:41/01-009/19/10_44) Local Contact: Medtronic International Ltd Contact no./Email: 6870 5300	HSA 6004101-009-19-10_44 FSN [PDF, 176 KB] (opens in new tab)
27 Jun 2019	Philips DigitalDiagnost Radiography System, Philips Medical Systems DMC GmbH (HSA 600:41/01-026/19/19_48) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-19-19_48 FSN [PDF, 179 KB] (opens in new tab)
26 Jun 2019	Hitachi Clinix II, Hitachi, Ltd (HSA 600:41/01-054/19/01_44) Local Contact: HITACHI MEDICAL SYSTEMS (S) PTE LTD Contact no./Email: 6602 0110 / operations.hmss.pj@hitachi.com	HSA 6004101-054-19-01_44 FSN [PDF, 95 KB] (opens in new tab)
24 Jun 2019	Occlutech Figulla Flex II ASD, Occlutech Holding AG (HSA 600:41/01-057/19/01_76) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: 6844 0002 / info@somnotec.net	HSA 6004101-057-19-01_76 FSN [PDF, 6755 KB] (opens in new tab)
24 Jun 2019	Sekisui Automated Coagulation Analyzer CP3000, Sekisui Medical Co. Ltd. (HSA 600:41/01-005/19/26_57) Local Contact: Abbott Laboratories (Singapore) Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-19-26_57 FSN [PDF, 697 KB] (opens in new tab)
20 Jun 2019	Single-Use Suction Valve, Olympus Medical Systems Corp. (HSA 600:41/01-004/19/03_76) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: mes-ra.osp@olympus-ap.com	HSA 6004101-004-19-03_76 FSN [PDF, 1469 KB] (opens in new tab)
20 Jun 2019	GE Revolution CT, GE Medical Systems, LLC (HSA 600:41/01-010/19/18_71) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-19-18_71 FSN [PDF, 114 KB] (opens in new tab)
19 Jun 2019	BD Vacutainer® Plastic Lithium Heparin Tubes, Becton, Dickinson and Company (HSA 600:41/01-003/19/06_70) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6664 2784	HSA 6004101-003-19-06_70 FSN [PDF, 148 KB] (opens in new tab)
19 Jun 2019	Ultra-Drive Irrigation Tubing Assembly, Biomet Orthopedics (HSA 600:41/01-008/19/04_51) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com	HSA 6004101-008-19-04_51 FSN [PDF, 366 KB] (opens in new tab)
18 Jun 2019	BD Connecta Plus 3-Stopcock, Becton Dickinson Infusion Therapy AB (HSA 600:41/01-003/19/05_54) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6664 2784	HSA 6004101-003-19-05_54 FSN [PDF, 122 KB] (opens in new tab)
18 Jun 2019	Carefusion Alaris System, CareFusion 303 Inc (HSA 600:41/01-003/19/04_77) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6664 2784	HSA 6004101-003-19-04_77 FSN [PDF, 233 KB] (opens in new tab)
17 Jun 2019	Defibrillation electrodes for adults for the Weinmann MEDUCORE Standard2 Monitor/Defibrillator, WEINMANN Emergency Medical Technology GmbH + Co. KG (HSA 600:41/01-301/19/02_64) Local Contact: EO Medical Pte. Ltd Contact no./Email: 6100 5060	HSA 6004101-301-19-02_64 FSN [PDF, 601 KB] (opens in new tab)
14 Jun 2019	ECG trunk cables and leadwires, GE Healthcare Finland Oy (HSA 600:41/01-010/19/17_79) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-19-17_79 FSN [PDF, 293 KB] (opens in new tab)
14 Jun 2019	cobas® 6800/8800 Systems Processing Transfer Head, Roche Diagnostics GmbH (HSA 600:41/01‐016/19/11_23) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-19-11_23 FSN [PDF, 472 KB] (opens in new tab)
13 Jun 2019	Alinity ci-series system control module, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/25_59) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-19-25_59 FSN [PDF, 304 KB] (opens in new tab)
12 Jun 2019	Philips Vereos PET/CT System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/19/18_37) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-19-18_37 FSN [PDF, 503 KB] (opens in new tab)
12 Jun 2019	ARCHITECT Ceruloplasmin, Alinity c Ceruloplasmin Reagent Kit, Sentinel CH (HSA 600:41/01-005/19/24_67) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-19-24_67 FSN [PDF, 1583 KB] (opens in new tab)
11 Jun 2019	Centricity Universal Viewer with Centricity PACS foundation 6.0 SP9 or higher used in combination with Centricity PACS 6.0 SP9 or higher, GE Healthcare (HSA 600:41/01-010/19/16_35) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668 / svc@ge.com	HSA 6004101-010-19-16_35 FSN [PDF, 141 KB] (opens in new tab)
11 Jun 2019	BrightView SPECT, BrightView X, BrightView XCT Handcontroller, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/19/17_38) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-19-17_38 FSN [PDF, 372 KB] (opens in new tab)
10 Jun 2019	EQUISTREAM®, EQUISTREAM® XK, AND GLIDEPATH® LONG-TERM HEMODIALYSIS CATHETERS, Bard Access Systems Inc (HSA 600:41/01-050/19/03_66) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 6664 2784 / complaints.singapore@crbard.com	HSA 6004101-050-19-03_66 FSN [PDF, 529 KB] (opens in new tab)
07 Jun 2019	UNI-GRAFT K DV (12 MM/15 CM), Aesculap AG (HSA 600:41/01‐012/19/03_54) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email:62130933 / bbraun.sg@bbraun.com	HSA 6004101-012-19-03_54 FSN [PDF, 1941 KB] (opens in new tab)
06 Jun 2019	Artis zee and Artis Q Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/12_62) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-19-12_62 FSN [PDF, 475 KB] (opens in new tab)
06 Jun 2019	Randox Human Assayed Multi-Sera-Level 2, Randox Laboratories Ltd (HSA 600:41/01-213/19/01_34) Local Contact: BioMedix Singapore Pte Ltd Contact no./Email: 6547 5591	HSA 6004101-213-19-01_34 FSN [PDF, 1667 KB] (opens in new tab)
06 Jun 2019	Alinity i BNP Calibrators, Alinity i BNP Controls, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/23_23) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8001 / FSN.enquiry@abbott.com	HSA 6004101-005-19-23_23 FSN [PDF, 375 KB] (opens in new tab)
06 Jun 2019	Weinmann MEDUCORE Standard2 Monitor/Defibrillator, Weinmann Emergency Medical Technology GmbH + Co. KG (HSA 600:41/01-301/19/01_48) Local Contact: EO Medical Pte Ltd Contact no./Email: 6100 5060	HSA 6004101-301-19-01_48 FSN [PDF, 111 KB] (opens in new tab)
06 Jun 2019	Sensation Plus 7.5 Fr. 40cc Intra-Aortic Balloon Catheter with Accessories, Datascope Corp. (HSA 600:41/01-224/19/06_35) Local Contact: Getinge South East Asia Pte Ltd Contact no./Email: 6296 1992	HSA 6004101-224-19-06_35 FSN [PDF, 491 KB] (opens in new tab)
06 Jun 2019	Spectra Optia Apheresis System, Terumo BCT (HSA 600:41/01-155/19/01_37) Local Contact: Terumo BCT Asia Pte Ltd Contact no./Email: 6715 3778 / Regulatory.Affairs@TerumoBCT.com	HSA 6004101-155-19-01_37 FSN [PDF, 121 KB] (opens in new tab)
03 Jun 2019	Elecsys Syphilis (200 test/kit), Roche Diagnostics GmbH (HSA 600:41/01-016/19/10_75) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-19-10_75 FSN [PDF, 339 KB] (opens in new tab)
03 Jun 2019	BD Microtainer Tubes, Becton Dickinson, Caribe Ltd. (HSA 600:41/01-003/19/03_73) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6432 2049	HSA 6004101-003-19-03_73 FSN [PDF, 129 KB] (opens in new tab)
02 Apr 2019	Bilirubin direct Gen 2, cobas c701/702, Roche Diagnostics GmbH (HSA 600:41/01-016/19/05_69) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-19-05_69 FSN [PDF, 129 KB] (opens in new tab) This FSN is an update to the original FSN published in Apr 2019.