Field Safety Notices

Field Safety Notice - Aug 2015

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 August 2015

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Table caption

Date of Notification	Title	FSN
31 Aug 2015	BD Affirm VP III Microbial Identification Test, Becton, Dickinson and Company (HSA 600:41/01-003/15/05_61) Local contact: Becton Dickinson Holdings Pte Ltd (BD) Contact no./ Email: 64322048	HSA 6004101-003-15-05_61 FSN [PDF, 81 KB] (opens in new tab)
27 Aug 2015	ADVIA Centaur HBsAgII, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/48_58) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-48_58 FSN [PDF, 89 KB] (opens in new tab)
26 Aug 2015	Watchman Left Atrial Appendage Closure Device with Delivery System and Watchman Access System Access Sheath with Dilator, Boston Scientific Corporation (HSA 600:41/01-007/15/04_56) Local contact: Boston Scientific Asia Pacific Pte Ltd Contact no./ Email: 64188888	HSA 6004101-007-15-04_56 FSN [PDF, 896 KB] (opens in new tab)
26 Aug 2015	Artis Zee and Artis Zeego systems, Siemens AG (HSA 600:41/01-022/15/46_17) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-46_17 FSN [PDF, 1566 KB] (opens in new tab)
26 Aug 2015	Disposable Reflective Marker Spheres (DRMS), BrainLab AG (HSA 600:41/01-047/15/05_55) Local contact: BrainLab Limited (Singapore Branch) Contact no./ Email: sg.sales@brainlab.com	HSA 6004101-047-15-05_55 FSN [PDF, 389 KB] (opens in new tab)
26 Aug 2015	ExacTrac 6.0 Patient Positioning System, BrainLab AG (HSA 600:41/01-047/15/06_48) Local contact: BrainLab Limited (Singapore Branch) Contact no./ Email: sg.sales@brainlab.com	HSA 6004101-047-15-06_48 FSN [PDF, 325 KB] (opens in new tab)
21 Aug 2015	ACUSON SC2000 ultrasound system, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/15/45_44) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-45_44 FSN [PDF, 1116 KB] (opens in new tab)
19 Aug 2015	ASP CIDEX® OPA Solution, Medos International Sarl (HSA 600:41/01-002/15/33_40) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-33_40 FSN [PDF, 50 KB] (opens in new tab)
19 Aug 2015	CARTO® 3 System, Biosense Webster, Inc (HSA 600:41/01-002/15/34_50) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-34_50 FSN [PDF, 70 KB] (opens in new tab)
18 Aug 2015	cobas 6800 system, Roche Diagnostics GmbH (HSA 600:41/01-016/15/15_20) Local contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./ Email: sg.regulatory@roche.com	HSA 6004101-016-15-15_20 FSN [PDF, 408 KB] (opens in new tab)
18 Aug 2015	Spiroflex AngioJet Thrombectomy Set, AngioJet Solent Omni, AngioJet Solent dista and AVX Thrombectomy Set, Bayer Medical Care Inc (HSA 600:41/01-070/15/16_49) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-16_49 FSN [PDF, 161 KB] (opens in new tab)
18 Aug 2015	Pioneer Plus Intravascular Ultrasound Guided Re-Entry Catheter, Volcano Corporation (HSA 600:41/01-070/15/17_36) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-17_36 FSN [PDF, 80 KB] (opens in new tab)
17 Aug 2015	Battery Power Line II Oscillator, Synthes GmbH (HSA 600:41/01-002/15/32_37) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-32_37 FSN [PDF, 1842 KB] (opens in new tab)
17 Aug 2015	Beacon Tip Angiographic Catheters, Cook Incorporated (HSA 600:41/01-013/15/04_33) Local contact: Cook South East Asia Pte Ltd Contact no./ Email: 62877888	HSA 6004101-013-15-04_33 FSN [PDF, 1980 KB] (opens in new tab)
17 Aug 2015	HQD Flow Probes, Transonic System Inc (HSA 600:41/01-070/15/15_35) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-15_35 FSN [PDF, 2762 KB] (opens in new tab)
13 Aug 2015	Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays, Zimmer Inc (HSA 600:41/01-008/15/08_25) Local contact: Zimmer Pte Ltd Contact no./ Email: 68547081	HSA 6004101-008-15-08_25 FSN [PDF, 202 KB] (opens in new tab)
13 Aug 2015	RIO Base Array, MAKO Surgical Corp (HSA 600:41/01-070/15/14_19) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-14_19 FSN [PDF, 25 KB] (opens in new tab)
12 Aug 2015	Access Thyroglobulin Reagent Kit, Beckman Coulter Inc (HSA 600:41/01-052/15/05_59) Local contact: Beckman Coulter Singapore Pte Ltd Contact no./ Email: 63407126	HSA 6004101-052-15-05_59 FSN [PDF, 31 KB] (opens in new tab)
11 Aug 2015	BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle with Integrated Holder, Becton, Dickinson and Company (HSA 600:41/01-003/15/03_17) Local contact: Becton Dickinson Holdings Pte Ltd (BD) Contact no./ Email: 64322048	HSA 6004101-003-15-03_17 FSN [PDF, 258 KB] (opens in new tab)
11 Aug 2015	BD MAX™ Clinical Instrument, Becton, Dickinson and Company (HSA 600:41/01-003/15/04_58) Local contact: Becton Dickinson Holdings Pte Ltd (BD) Contact no./ Email: 64322048	HSA 6004101-003-15-04_58 FSN [PDF, 48 KB] (opens in new tab)
06 Aug 2015	Beckman Coulter MicroScan® Pos MIC 26, Beckman Coulter Inc (HSA 600:41/01-052/15/04_57) Local contact: Beckman Coulter Singapore Pte Ltd Contact no./ Email: 63407126	HSA 6004101-052-15-04_57 FSN [PDF, 1420 KB] (opens in new tab)
05 Aug 2015	Cidex Activated Glutaraldehyde Solution, Advanced Sterilization Products (HSA 600:41/01-002/15/29_54) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-29_54 FSN [PDF, 60 KB] (opens in new tab)
05 Aug 2015	VEPTR® Vertical Expandable Prosthetic Titanium Rib Caudal Rib Supports, Synthes GmbH (HSA 600:41/01-002/15/30_46) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-30_46 FSN [PDF, 290 KB] (opens in new tab)
05 Aug 2015	Socket, Hexagonal Ø 4.0mm/11.0mm, Synthes GmbH (HSA 600:41/01-002/15/31_56) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-31_56 FSN [PDF, 45 KB] (opens in new tab)
04 Aug 2015	ASP6025 Tissue Processor, Leica Biosystems Nussloch GmbH (HSA 600:41/01-126/15/02_31) Local contact: Leica Microsystems (SEA) Pte Ltd Contact no./ Email: 65505975	HSA 6004101-126-15-02_31 FSN [PDF, 1334 KB] (opens in new tab)
04 Aug 2015	ASP200s/300s Tissue Processor, Leica Biosystems Nussloch GmbH (HSA 600:41/01-126/15/03_38) Local contact: Leica Microsystems (SEA) Pte Ltd Contact no./ Email: 65505975	HSA 6004101-126-15-03_38 FSN [PDF, 1441 KB] (opens in new tab)