Field Safety Notices

Field Safety Notice - Dec 2018

31 December 2018

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 Dec 2018	Biomet Series A Standard Patella, Biomet Orthopedics (HSA 600:41/01-008/18/21_79) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com	HSA 6004101-008-18-21_79 FSN_Redacted [PDF, 237 KB] (opens in new tab)
28 Dec 2018	Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter, Biomet Orthopedics (HSA 600:41/01-008/18/20_74) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com	HSA 6004101-008-18-20_74 FSN_Redacted [PDF, 264 KB] (opens in new tab)
27 Dec 2018	Panocell-16, Immucor, Inc (HSA 600:41/01-033/18/07_69) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com	HSA 6004101-033-18-07_69 FSN_Redacted [PDF, 43 KB] (opens in new tab)
27 Dec 2018	Covidien Emprint™ Percutaneous Antenna with Thermospere™ Technology, Covidien llc (HSA 600:41/01-046/18/13_63) Local Contact: Covidien Private Limited Contact no./Email: 6439 6974	HSA 6004101-046-18-13_63 FSN_Redacted [PDF, 207 KB] (opens in new tab)
27 Dec 2018	Allura Xper FD2O OR Table and Azurion 7 M20 with a Trumpf Table, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/38_46) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-38_46 FSN_Redacted [PDF, 336 KB] (opens in new tab)
26 Dec 2018	Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion, Panorama HFO, Ingenia, SmartPath to dStream, Multiva, Prodiva, MR-OR, MR-RT, MR-Linac, MR-Marlin systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/36_44) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-36_44 FSN_Redacted [PDF, 479 KB] (opens in new tab)
26 Dec 2018	Draeger VentStar breathing circuits, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/18/06_71) Local Contact: Draeger Singapore Pte Ltd Contact no./Email: 6872 9288 / draeger.sg@draeger.com	HSA 6004101-063-18-06_71 FSN_Redacted [PDF, 2741 KB] (opens in new tab)
26 Dec 2018	Philips Digital Diagnost C50 System, Philips Healthcare(Suzhou) Co. Ltd (HSA 600:41/01-026/18/37_50) Local Contact: Philips Electronics(Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-37_50 FSN_Redacted [PDF, 9758 KB] (opens in new tab)
24 Dec 2018	Discovery NM 530c and Ventri Nuclear Medicine Systems, GE medical Systems Israel, Functional Imaging (HSA 600:41/01-010/18/29_37) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-29_37 FSN_Redacted [PDF, 384 KB] (opens in new tab)
23 Dec 2018	Check-Flo Performer® Introducer, Cook Incorporated (HSA 600:41/01-013/18/14_63) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-18-14_63 FSN_Redacted [PDF, 153 KB] (opens in new tab)
21 Dec 2018	Confirm Rx Insertable Cardiac Monitor, St Jude Medical Cardia Rhythm Management Division (HSA 600:41/01-005/18/27_52) Local Contact: Abbott Medical (Singapore) Pte Ltd Contact no./Email: 6914 8000	HSA 6004101-005-18-27_52 FSN_Redacted [PDF, 53 KB] (opens in new tab)
21 Dec 2018	Alinity i Processing Module, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/28_34) Local Contact: Abbott Laboratories (S) Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-18-28_34 FSN_Redacted [PDF, 379 KB] (opens in new tab)
21 Dec 2018	da Vinci Harmonic ACE Insert, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/27_38) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regional.pms@transmedicgroup.com	HSA 6004101-070-18-27_38 FSN [PDF, 205 KB] (opens in new tab)
21 Dec 2018	EliA ANA Positive Control, Phadia AB (HSA 600:41/01-033/18/06_61) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com	HSA 6004101-033-18-06_61 FSN_Redacted [PDF, 731 KB] (opens in new tab)
20 Dec 2018	Leica M220 F12, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/18/06_48) Local Contact: Leica Instruments Singapore Pte Ltd Contact no./Email: 6569 1828	HSA 6004101-126-18-06_48 FSN_Redacted [PDF, 1580 KB] (opens in new tab)
20 Dec 2018	Cobas t 711 coagulation analyser, Roche Diagnostics GmbH (HSA 600:41/01-016/18/20_73) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-20_73 FSN [PDF, 1914 KB] (opens in new tab)
20 Dec 2018	IV Pole Collar for Spectra Optia® and Trima Accel® Apheresis System, Terumo BCT Inc (HSA 600:41/01-155/18/02_62) Local Contact: Terumo BCT Asia Pte Ltd Contact no./Email: 6715 3778 / apac.communications@terumobct.com	HSA 6004101-155-18-02_62 FSN_Redacted [PDF, 213 KB] (opens in new tab)
19 Dec 2018	COULTER® EPICS® XL™ Flow Cytometer with System II Software, COULTER EPICS XL-MCL™ Flow Cytometer with System II Software, and FC 500 Series Flow Cytometers, Beckman Coulter Inc (HSA 600:41/01-052/18/07_49) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-18-07_49 FSN_Redacted [PDF, 2074 KB] (opens in new tab)
18 Dec 2018	Philips Hemodynamic Application R1.0.1, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/35_62) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-35_62 FSN_Radacted [PDF, 1930 KB] (opens in new tab)
17 Dec 2018	Entuit Secure Gastrointestinal Suture Anchor Set, Cook Incorporated (HSA 600:41/01-013/18/13_48) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 68127400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-18-13_48 FSN_Redacted [PDF, 155 KB] (opens in new tab)
17 Dec 2018	GE Healthcare MRI Systems, GE Healthcare (HSA 600:41/01-010/18/28_52) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-28_52 FSN_Redacted [PDF, 476 KB] (opens in new tab)
17 Dec 2018	IBA Proteus ONE Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/18/26_76) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6102 / regional.pms@transmedicgroup.com	HSA 6004101-070-18-26_76 FSN_Redacted [PDF, 671 KB] (opens in new tab)
17 Dec 2018	StealthAir Percutaneous Pin Adapter, Medtronic Navigation, Inc (HSA 600:41/01-009/18/22_56) Local Contact: Medtronic International Ltd. Contact no./Email: 6439 5000	HSA 6004101-009-18-22_56 FSN_Redacted [PDF, 193 KB] (opens in new tab)
17 Dec 2018	Modified ONFLEX mesh, Davol, Inc (HSA 600:41/01-050/18/08_44) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 6580 5988 / Complaint.Singapore@crbard.com	HSA 6004101-050-18-08_44 FSN [PDF, 79 KB] (opens in new tab)
17 Dec 2018	Cardiovit MS-2007/2010/2015, Schiller AG (HSA 600:41/01-056/18/05_43) Local Contact: Gold Lite Contact no./Email: 6273 0487	HSA 6004101-056-18-05_43 FSN_Redacted [PDF, 2960 KB] (opens in new tab)
15 Dec 2018	Cook Zenith Alpha Abdominal Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013/18/12_54) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-18-12_54 FSN_Redacted [PDF, 536 KB] (opens in new tab)
15 Dec 2018	Cook Cirrus-14 Wire Guide, William Cook Europe Aps (HSA 600:41/01-013/18/09_66) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-18-09_66 FSN_Redacted [PDF, 1322 KB] (opens in new tab)
14 Dec 2018	Accutrend BM-Lactate, Roche Diagnostics GmbH (HSA 600:41/01-016/18/18_75) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-18_75 FSN [PDF, 462 KB] (opens in new tab)
14 Dec 2018	Medtronic HeartWare™ HVAD™ System Battery Charger, HeartWare (HSA 600:41/01-263/18/05_56) Local Contact: Emergo Consulting Pte Ltd Contact no./Email: 6854 7976 / SEAsiaVigilance@ul.com	HSA 6004101-263-18-05_56 FSN [PDF, 145 KB] (opens in new tab)
14 Dec 2018	PROXIMATE® Hemorrhoidal Circular Stapler, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/09_51) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6918 8304	HSA 6004101-002-18-09_51 FSN_Redacted [PDF, 554 KB] (opens in new tab)
14 Dec 2018	MOSAIQ Radiation Oncology, Elekta, Inc. (HSA 600:41/01-101/18/06_63) Local Contact: ELEKTA PTE. LTD. Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com	HSA 6004101-101-18-06_63 FSN_Redacted [PDF, 1656 KB] (opens in new tab)
14 Dec 2018	cobas Bilirubin Total Gen 3, Lactate Gen 2 and Tinaquant IgM Gen 2, Roche Diagnostics GmbH (HSA 600:41/01-016/18/19_31) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-19_31 FSN [PDF, 151 KB] (opens in new tab)
14 Dec 2018	Lag Screw 3.2mm Guide Pin, Smith & Nephew Inc (HSA 600:41/01-073/18/21_38) Local Contact: Smith & Nephew Pte Limited Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-21_38 FSN [PDF, 98 KB] (opens in new tab)
14 Dec 2018	Journey DCF AP Femoral Cutting Block Size 3, Smith & Nephew Inc (HSA 600:41/01-073/18/20_71) Local Contact: Smith & Nephew Pte Limited Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-20_71 FSN [PDF, 98 KB] (opens in new tab)
12 Dec 2018	Merci® Ballon Guide Catheter, Stryker Neurovascular (HSA 600:41/01-070/18/25_79) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6102 / regional.pms@transmedicgroup.com	HSA 6004101-070-18-25_79 FSN [PDF, 197 KB] (opens in new tab)
12 Dec 2018	Roche Diagnostics cobas c111 analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/18/17_70) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-17_70_FSN [PDF, 108 KB] (opens in new tab)
12 Dec 2018	ATELLICA IM ANTI-THYROGLOBULIN (ATG) / ADVIA CENTAUR ANTI-THYROGLOBULIN (ATG), Siemens Healthcare Diagnostics Limited (HSA 600:41/01-022/18/29_57) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-29_57_FSN [PDF, 7343 KB] (opens in new tab)
12 Dec 2018	Ingenia Elition S, Ingenia Elition X MR Systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/34_74) Local Contact: Philips Electronic (Singapore) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-18-34_74 FSN_Redacted [PDF, 462 KB] (opens in new tab)
12 Dec 2018	Legion Pressfit Stem, Smith & Nephew Inc (HSA 600:41/01-073/18/19_68) Local Contact: Smith & Nephew Pte Limited Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-19_68 FSN [PDF, 98 KB] (opens in new tab)
12 Dec 2018	Ortho Clinical VITROS Chemistry Products VALP Reagent, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/18_73) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 6486 1151	HSA 6004101-303-18-18_73 FSN [PDF, 367 KB] (opens in new tab)
11 Dec 2018	Olympus Airway Mobilescope, Ultrasonic Bronchofiberscope, Ultrasonic Bronchofibervideoscope, Bronchofiberscope, Bronchofibervideoscope, Rhino-Laryngo Videoscope, Olympus Medical Systems Corp; Olympus Optical Co. (HSA 600:41/01-004/18/03_44) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: mes-ra.osp@olympus-ap.com	HSA 6004101-004-18-03_44 FSN_Redacted [PDF, 1522 KB] (opens in new tab)
11 Dec 2018	COBAS INTEGRA 400 plus, Roche Diagnostics GmbH (HSA 600:41/01-016/18/16_34) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-16_34 FSN [PDF, 140 KB] (opens in new tab)
11 Dec 2018	Sekisui Automated Coagulation Analyzer CP3000, Sekisui Medical Co. Ltd. (HSA 600:41/01-005/18/26_70) Local Contact: Abbott Laboratories (S) Pte Ltd Contact no./Email: 6914 8000 / FSN@enquiry@abbott.com	HSA 6004101-005-18-26_70 FSN [PDF, 198 KB] (opens in new tab)
10 Dec 2018	da Vinci® Xi/X Surgical System Arm Sensor for Intuitive Surgical® da Vinci® Xi® Endoscopic Control System(da Vinci Xi System) and Endoscopic instruments, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/24_18) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6102 / regional.pms@transmedicgroup.com	HSA 6004101-070-18-24_18 FSN_Redacted [PDF, 184 KB] (opens in new tab)
06 Dec 2018	lnvivo Xper Flex Cardio Physiomonitoring System, INVIVO, a division of Philips Medical Systems (HSA 600:41/01-026/18/33_46) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-18-33_46 FSN_Redacted [PDF, 125 KB] (opens in new tab)
06 Dec 2018	Nanoknife Disposable Single Electrode Probes, AngioDynamic Inc (HSA 600:41/01-331/18/01_37) Contact no./Email: regulatory_admin@elc-group.com	HSA 6004101-331-18-01_37 FSN_Redacted [PDF, 421 KB] (opens in new tab)
05 Dec 2018	VITROS Immunodiagnostic Products Myoglobin Calibrators, Ortho-Clinical Diagnostics (HSA 600:41/01-303/18/17_49) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 6486 1151	HSA 6004101-303-18-17_49 FSN [PDF, 257 KB] (opens in new tab)
04 Dec 2018	Elekta Mosaiq, Elekta, Inc (HSA 600:41/01-101/18/05_76) Local Contact: Elekta Pte. Ltd. Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com	HSA 6004101-101-18-05_76 FSN_Redacted [PDF, 1684 KB] (opens in new tab)
03 Dec 2018	SD BIOLINE Chikungunya IgM, Standard Diagnostics Inc (HSA 600:41/01-111/18/02_23) Local Contact: Unison Collaborative Pte Ltd Contact no./Email: 6734 5577 / info@unicoll.com.sg	HSA 6004101-111-18-02_23 FSN_Redacted [PDF, 4710 KB] (opens in new tab)
03Dec 2018	multiFiltrate Pro, Frensenius Medical Care AG & Co. KGaA (HSA 600:41/01-062/18/03_50) Local Contact: Frensenius Medical Care Singapore Pte Ltd Contact no./Email: 6837 3113 / enquiry.SG@fmc-asia.com	HSA 6004101-062-18-03_50 FSN_Redacted [PDF, 2315 KB] (opens in new tab)