Field Safety Notices

Field Safety Notice - Dec 2018

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 December 2018

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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)