Field Safety Notices

Field Safety Notice - Jun 2015

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 June 2015

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Table caption

Date of Notification	Title	FSN
30 Jun 2015	Stryker Neurovascular Target™ Detachable Coils (HSA 600:41/01-148/15/02_34) Local contact: DKSH Singapore Pte Ltd	HSA 6004101-148-15-02_34 FSN [PDF, 441 KB] (opens in new tab)
30 Jun 2015	Biomet Orthopaedic products - i) Biomet Finned Primary Stem, ii) Biomet Cobalt-Chrome Femoral Components, Biomet Orthopedics(HSA 600:41/01-183/15/04_45) Local contact: JJ Medsurg Pte Ltd	HSA 6004101-183-15-04_45 FSN [PDF, 261 KB] (opens in new tab)
29 Jun 2015	Navigation System II-Cart / ARTICULATED ARM CAMERA, Stryker Leibinger GmbH & Co.KG (HSA 600:41/01-014/15/06_36) Local contact: Stryker Singapore Pte Ltd	HSA 6004101-014-15-06_36 FSN [PDF, 38 KB] (opens in new tab)
29 Jun 2015	Siemens Artis System, Siemens AG (HSA 600:41/01-022/15/32_37) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-32_37 FSN [PDF, 1766 KB] (opens in new tab)
29 Jun 2015	Accuson S Series Ultrasound, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/15/33_18) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-33_18 FSN [PDF, 1417 KB] (opens in new tab)
29 Jun 2015	ACUSON S series, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/15/34_17) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-34_17 FSN [PDF, 696 KB] (opens in new tab)
29 Jun 2015	ACS NT, Intera 1.5T and Achieva 1.5T MR Systems with the SENSE Body Coil 1.5T., Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/15/22_25) Local contact: Philips Electronics (S) Pte Ltd	HSA 6004101-026-15-22_25 FSN [PDF, 358 KB] (opens in new tab)
29 Jun 2015	Oxford Femoral Drill Guide Lateral IM Adapter, Biomet Orthopedics (HSA 600:41/01-183/15/03_16) Local contact: JJ Medsurg Pte Ltd	HSA 6004101-014-15-03_16 FSN [PDF, 25 KB] (opens in new tab)
29 Jun 2015	Fabius MRI Anaesthesia System, Draeger Medical GmbH (HSA 600:41/01-063/15/01_39) Local contact: Draeger Medical SEA Pte Ltd	HSA 6004101-063-15-01_39 FSN [PDF, 2995 KB] (opens in new tab)
25 Jun 2015	Somatom Emotion, Siemens Shanghai Medical Equipment Ltd (HSA 600:41/01-022/15/30_16) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-30_16 FSN [PDF, 2837 KB] (opens in new tab)
25 Jun 2015	Artis systems, Siemens AG (HSA 600:41/01-022/15/31_19) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-31_19 FSN [PDF, 1516 KB] (opens in new tab)
25 Jun 2015	T-Lok Bone Marrow Biopsy Needle, Argon Medical Devices, Inc. (HSA 600:41/01-278/15/01_18) Local contact: SingMed Healthcare Systems	HSA 6004101-278-15-01_18 FSN [PDF, 209 KB] (opens in new tab)
24 Jun 2015	Pull Reduction Device for Percutaneous Drill Guide Ø 4.3mm, Synthes GmbH (HSA 600:41/01-002/15/26_35) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-26_35 FSN [PDF, 73 KB] (opens in new tab)
24 Jun 2015	IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 Xpi, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/15/29_32) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-29_32 FSN [PDF, 102 KB] (opens in new tab)
24 Jun 2015	All EndoWrist instruments used with the da Vinci Xi Surgical System., Intuitive Surgical Inc (HSA 600:41/01-070/15/11_20) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-11_20 FSN [PDF, 65 KB] (opens in new tab)
24 Jun 2015	GlideScope Reusable GVL and AVL Blades, Verathon Medical Inc (HSA 600:41/01-076/15/01_17) Local contact: Radiance Medical Systems	HSA 6004101-076-15-01_17 FSN [PDF, 128 KB] (opens in new tab)
24 Jun 2015	rHead, uHead, Sigmoid Notch, ReMotion, Radio Capitellum, Stryker Trauma AG (HSA 600:41/01-226/15/01_33) Local contact: Gen-Y (S) Pte Ltd	HSA 6004101-226-15-01_33 FSN [PDF, 220 KB] (opens in new tab)
22 Jun 2015	Medtronic DLP® Femoral Arterial Cannula and Medtronic DLP® Femoral Cannula and Insertion Kit, Medtronic, Inc (HSA 600:41/01-009/15/08_19) Local contact: Medtronic International Limited	HSA 6004101-009-15-08_19 FSN [PDF, 33 KB] (opens in new tab)
22 Jun 2015	Per-Q-Cath line of products, Bard Access Systems Inc (HSA 600:41/01-050/15/03_31) Local contact: Bard Singapore Pte Ltd	HSA 6004101-050-15-03_31 FSN [PDF, 2391 KB] (opens in new tab)
19 Jun 2015	ATTUNE® INTUITION™ Tibial Articulation Surface Instruments, DePuy Ireland (HSA 600:41/01-002/15/25_16) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-25_16 FSN [PDF, 329 KB] (opens in new tab)
19 Jun 2015	3M ESPE Lava Ultimate CAD/CAM Restorative and 3M™ ESPE™ Lava™ Ultimate Implant Crown Restorative, 3M ESPE Dental Products (HSA 600:41/01-031/15/01_20) Local contact: 3M Technologies (S) Pte Ltd	HSA 6004101-031-15-01_20 FSN [PDF, 192 KB] (opens in new tab)
19 Jun 2015	da Vinci® Xi™ System Draping - Instrument Arm Drape, Intuitive Surgical Inc (HSA 600:41/01-070/15/10_17) Local contact: Intuitive Surgical Inc	HSA 6004101-070-15-10_17 FSN [PDF, 490 KB] (opens in new tab)
18 Jun 2015	Tracoe vario Tracheostomy Tube with Atraumatic Insertion System, Tracoe Medical GmbH (HSA 600:41/01-149/15/01_18) Local contact: I:Emedics Pte Ltd	HSA 6004101-149-15-01_18 FSN [PDF, 79 KB] (opens in new tab)
17 Jun 2015	SERFAS 90deg Energy Probe, Stryker Endoscopy (HSA 600:41/01-014/15/05_17) Local contact: Stryker Singapore Pte Ltd	HSA 6004101-014-15-05_17 FSN [PDF, 37 KB] (opens in new tab)
17 Jun 2015	Toshiba whole-body X-ray CT scanners, Toshiba Medical System Corporation (HSA 600:41/01-064/15/02_16) Local contact: Toshiba Medical Systems Asia Pte Ltd	HSA 6004101-064-15-02_16 FSN [PDF, 334 KB] (opens in new tab)
17 Jun 2015	Weinmann SOMNOvent CR CS Therapy Device, Weinmann Gerate fur Medizin GmbH + Co. KG (HSA 600:41/01-264/15/02_20) Local contact: Easmed Asia Pte Ltd	HSA 6004101-264-15-02_20 FSN [PDF, 80 KB] (opens in new tab)
16 Jun 2015	ALT/ALTL, AST/ASTL, CKMBL, GLDH, NH3L, Roche Diagnostics GmbH (HSA 600:41/01-016/15/11_19) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-11_19 FSN [PDF, 1310 KB] (opens in new tab)
16 Jun 2015	Bedfont Scientifc NOxBOXi® Intelligent Nitric Oxide Delivery and Monitoring System, Bedfont Scientific Ltd (HSA 600:41/01-199/15/02_18) Local contact: Junnimed Services Pte Ltd	HSA 6004101-199-15-02_18 FSN [PDF, 538 KB] (opens in new tab)
15 Jun 2015	Osteotomy Guiding Device, Synthes GmbH (HSA 600:41/01-002/15/23_24) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-23_24 FSN [PDF, 2723 KB] (opens in new tab)
15 Jun 2015	Cortex Screw Ø 4.5 mm, length 105 mm, Pure Titanium, Synthes GmbH (HSA 600:41/01-002/15/24_25) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-24_25 FSN [PDF, 1725 KB] (opens in new tab)
15 Jun 2015	VariSource iX Console software with Magnetic Hard Disk Drive only, Varian Medical Systems (HSA 600:41/01-058/15/01_23) Local contact: Varian Medical Systems Pacific Inc.	HSA 6004101-058-15-01_23 FSN [PDF, 2172 KB] (opens in new tab)
15 Jun 2015	Agfa Healthcare DX-D100 Mobile Direct Radiography (DR) System, Agfa HealthCare N.V., Inc (HSA 600:41/01-184/15/01_22) Local contact: Agfa HealthCare Singapore Pte Ltd	HSA 6004101-184-15-01_22 FSN [PDF, 106 KB] (opens in new tab)
12 Jun 2015	Philips Efficia DFM 100 Defibrillator/Monitors, Philips Goldway (Shenzhen) Industrial Inc (HSA 600:41/01-026/15/21_22) Local contact: Philips Electronics (S) Pte Ltd	HSA 6004101-026-15-21_22 FSN [PDF, 26 KB] (opens in new tab)
12 Jun 2015	PROCISE EZ VIEW & EVAC 70 XTRA, ArthroCare Corporation (HSA 600:41/01-073/15/06_24) Local contact: Smith & Nephew Pte Ltd	HSA 6004101-073-15-06_24 FSN [PDF, 87 KB] (opens in new tab)
12 Jun 2015	Alcon Monarch IOL Delivery System Cartridges, Alcon Laboratories, Inc (HSA 600:41/01-135/15/03_25) Local contact: Alcon Pte Ltd	HSA 6004101-135-15-03_25 FSN [PDF, 208 KB] (opens in new tab)
11 Jun 2015	S4C Occiput Torque Wrench F/Set Screw, Aesculap AG (HSA 600:41/01-012/15/05_20) Local contact: B. Braun Singapore Pte Ltd	HSA 6004101-012-15-05_20 FSN [PDF, 677 KB] (opens in new tab)
11 Jun 2015	Q-Station, Philips Ultrasound, Inc. (HSA 600:41/01-026/15/20_17) Local contact: Philips Electronics (S) Pte Ltd	HSA 6004101-026-15-20_17 FSN [PDF, 529 KB] (opens in new tab)
11 Jun 2015	Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Integra NeuroSciences (HSA 600:41/01-070/15/09_16) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-09_16 FSN [PDF, 2229 KB] (opens in new tab)
10 Jun 2015	PenAdapt, Stryker Instruments (HSA 600:41/01-014/15/04_17) Local contact: Stryker Singapore Pte Ltd	HSA 6004101-014-15-04_17 FSN [PDF, 310 KB] (opens in new tab)
10 Jun 2015	Ultraview SL Command Module with the Masimo SpO2 PCBA, Spacelabs Healthcare, Inc. (HSA 600:41/01-029/15/01_19) Local contact: SpaceLabs Healthcare Pte Ltd	HSA 6004101-029-15-01_19 FSN [PDF, 75 KB] (opens in new tab)
10 Jun 2015	STOCKERT Heater Cooler system 3T , STOCKERT Heater-Cooler S3 WKS2, Sorin Group Deutschland GmbH (HSA 600:41/01-095/15/01_18) Local contact: Sorin Group Asia Pte Ltd	HSA 6004101-095-15-01_18 FSN [PDF, 536 KB] (opens in new tab)
09 Jun 2015	Medtronic StealthStation® S7™ Treatment Guidance System (Spinal), Medtronic Navigation, Inc. (HSA 600:41/01-009/15/07_20) Local contact: Medtronic International Limited	HSA 6004101-009-15-07_20 FSN [PDF, 227 KB] (opens in new tab)
09 Jun 2015	5mm Thoracic Grasper, Intuitive Surgical Inc (HSA 600:41/01-070/15/08_16) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-08_16 FSN [PDF, 453 KB] (opens in new tab)
08 Jun 2015	MiniMed Sure-T infusion Sets, Medtronic, Inc (HSA 600:41/01-009/15/06_19) Local contact: Medtronic International Limited	HSA 6004101-009-15-06_19 FSN [PDF, 133 KB] (opens in new tab)
08 Jun 2015	Berichrom Protein C, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/15/01_18) Local contact: Sysmex Asia Pacific Pte Ltd	HSA 6004101-032-15-01_18 FSN [PDF, 134 KB] (opens in new tab)
05 Jun 2015	Coroflex ISAR Sirolimus Eluting Coronary stent, B. Braun Melsungen AG (HSA 600:41/01-012/15/04_18) Local contact: B. Braun Singapore Pte Ltd	HSA 6004101-012-15-04_18 FSN [PDF, 1822 KB] (opens in new tab)
05 Jun 2015	InTouch Critical Care Bed, Stryker Medical (HSA 600:41/01-014/15/03_16) Local contact: Stryker Singapore Pte Ltd	HSA 6004101-014-15-03_16 FSN [PDF, 25 KB] (opens in new tab)
05 Jun 2015	MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/15/19_16) Local contact: Philips Electronics (S) Pte Ltd	HSA 6004101-026-15-19_16 FSN [PDF, 241 KB] (opens in new tab)
05 Jun 2015	Volcano PV. 035 Catheter and Volcano Prestige Plus 185cm J-Tip, Volcano Corporation (HSA 600:41/01-070/15/07_19) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-07_19 FSN [PDF, 176 KB] (opens in new tab)
05 Jun 2015	Birmingham Hip Resurfacing System, Smith & Nephew Orthopaedics (HSA 600:41/01-073/15/05_17) Local contact: Smith & Nephew Pte Ltd	HSA 6004101-073-15-05_17 FSN [PDF, 672 KB] (opens in new tab)
05 Jun 2015	Hoffrichter Trend II, point and Vector et, Hoffrichter GmbH (HSA 600:41/01-112/15/02_20) Local contact: Rainbow Care Pte Ltd	HSA 6004101-112-15-02_20 FSN [PDF, 9385 KB] (opens in new tab)
05 Jun 2015	Accurus 2500 Stand-Alone Vitreous Probe, Accurus 23 GA Standalone Vitreous Probe, Accurus 25+ 2500 CPM Stand-Alone Vitreous Probe, Anterior Accurus Probe with Infusion Needle, Alcon Laboratories, Inc (HSA 600:41/01-135/15/02_35) Local contact: Alcon Pte Ltd	HSA 6004101-135-15-02_35 FSN [PDF, 383 KB] (opens in new tab)
05 Jun 2015	US Endoscopy Talon grasping device, US Endoscopy (HSA 600:41/01-258/15/01_17) Local contact: Kenda (S) Pte Ltd	HSA 6004101-258-15-01_17 FSN [PDF, 54 KB] (opens in new tab)
04 Jun 2015 [PDF, 94 KB] (opens in new tab) [PDF, 94 KB] (opens in new tab)	Innova, Optima and Discovery Interventional systems, GE Medical Systems SCS (HSA 600:41/01-010/15/10_34) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-10_34 FSN [PDF, 56 KB] (opens in new tab)
03 Jun 2015	Smiths Medical CADD®-Solis Ambulatory Infusion Pumps, Smiths Medical ASD, Inc (HSA 600:41/01-017/15/07_32) Local contact: IDS Medical Systems Pte Ltd	HSA 6004101-017-15-07_32 FSN [PDF, 229 KB] (opens in new tab)
03 Jun 2015	IMMULITE® 2000/IMMULITE® 2000 Xpi Italian Cypress allergen, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/15/28_33) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-28_33 FSN [PDF, 94 KB] (opens in new tab)
02 Jun 2015	SofPort Advanced Optics Aspheric IOL & SoFlex SE Foldable Intraocular Lens, Bausch & Lomb, Incorporated (HSA 600:41/01-030/15/03_31) Local contact: Bausch & Lomb (Singapore) Pte Ltd	HSA 6004101-030-15-03_31 FSN [PDF, 105 KB] (opens in new tab)