Field Safety Corrective Actions (FSCA) include removals of medical devices from the market or any other corrective action on devices in use. In general, the product owner (otherwise known as legal manufacturer) implements FSCAs by sending a Field Safety Notice (FSN) to inform operators and users about risks of medical devices. It includes advice on what action should be taken to protect the health or the safety of patients, users or other persons. For example, FSNs may contain information from the product owner that they are voluntarily recalling specific lots of a medical device.

Please note that FSNs are issued by the product owner, registrant or importer of medical devices pursuant to the requirements under the Health Products Act (Cap. 122D). These persons take full responsibility for all information contained in the FSN.

If you receive a FSN from a product owner, registrant or importer, you must always act on it. The Health Sciences Authority makes FSNs publicly available for information only.

If you have a specific question on a FSN, please contact* the product owner, registrant or importer (as the case may be).

*Any contact information provided for each FSCA is correct as at the date of the FSCA notification to the Health Sciences Authority.

Field Safety Notice - Jun 2019

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 FSN998 KB
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 FSN649 KB
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 FSN1631 KB
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 FSN176 KB
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 FSN178 KB
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 FSN95 KB
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 FSN6755 KB
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 FSN696 KB
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 FSN1468 KB
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 FSN113 KB
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 FSN147 KB
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 FSN366 KB
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 FSN122 KB
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 FSN232 KB
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 FSN600 KB
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 FSN292 KB
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 FSN472 KB
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 FSN303 KB
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 FSN502 KB
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 FSN1582 KB
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 FSN141 KB
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 FSN372 KB
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 FSN529 KB
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 FSN1941 KB
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 FSN475 KB
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 FSN1666 KB
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 FSN374 KB
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 FSN111 KB
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 FSN490 KB
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 FSN120 KB
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 FSN339 KB
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 FSN128 KB
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 FSN128 KB This FSN is an update to the original FSN published in Apr 2019.

Healthcare professional, Industry member, Medical devices

Published: 30 Jun 2019

Field Safety Notices

20 Mar 2020