Field Safety Notices

Field Safety Notice - Mar 2016

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 March 2016

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Table caption

DATE OF NOTIFICATION	TITLE	FSN
31 Mar 2016	PneumoSure High Flow Insufflator High Pressure Unit, Stryker Endoscopy (HSA 600:41/01-014/16/02_19) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: 65009527	HSA 6004101-014-16-02_19 FSN [PDF, 205 KB] (opens in new tab) HSA 6004101-014-16-02_19 FSN [PDF, 161 KB] (opens in new tab)
31 Mar 2016	Brilliance CT and Ingenuity CT, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/16/07_18) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-07_18 FSN [PDF, 95 KB] (opens in new tab)
31 Mar 2016	Power Cross .018 OTW PTA Dilatation Catheter, ev3 Inc (HSA 600:41/01-046/16/03_17) Local Contact: Covidien Private Limited Contact no./Email: 64396974	HSA 6004101-046-16-03_17 FSN [PDF, 190 KB] (opens in new tab)
31 Mar 2016	CELL-DYN Emerald Cleaner, Abbott Diagnostics Division (HSA 600:41/01-005/16/05_38) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: FSN.enquiry@abbott.com	HSA 6004101-005-16-05_38 FSN [PDF, 504 KB] (opens in new tab)
31 Mar 2016	ADVIA Centaur CP System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/14_58) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-14_58 FSN [PDF, 102 KB] (opens in new tab)
30 Mar 2016	4500MD LC/MS/MS System, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/02_34) Local Contact: AB SCIEX Pte Ltd Contact no./Email: 63043722	HSA 6004101-255-16-02_34 FSN [PDF, 93 KB] (opens in new tab)
30 Mar 2016	MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/16/06_08) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-06_08 FSN [PDF, 102 KB] (opens in new tab)
30 Mar 2016	ROTEM platelet Cuvettes, Tem Innovations GmbH (HSA 600:41/01-118/16/02_31) Local Contact: Unimed Healthcare Pte Ltd Contact no./Email: enquiry@unimed.com.sg	HSA 6004101-118-16-02_31 FSN [PDF, 850 KB] (opens in new tab)
29 Mar 2016	ARCHITECT Estradiol Reagent, Abbott Ireland Diagnostic Division (HSA 600:41/01-005/16/04_24) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: FSN.enquiry@abbott.com	HSA 6004101-005-16-04_24 FSN [PDF, 52 KB] (opens in new tab)
29 Mar 2016	Osseofix Sterile Package Implant 5.5mm, Alphatec Spine Inc (HSA 600:41/01-115/16/01_56) Local Contact: Opto Systems (S) Pte Ltd Contact no./Email: admin@optosystems.com.sg	HSA 6004101-115-16-01_56 FSN [PDF, 2084 KB] (opens in new tab)
29 Mar 2016	Fetch™ 2 Aspiration Catheter, Boston Scientific Corporation (HSA 600:41/01-070/16/09_52) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com	HSA 6004101-070-16-09_52 FSN [PDF, 53 KB] (opens in new tab)
29 Mar 2016	Proximal Femoral Nail Ø 10.0mm cannulated, 130°, L 380mm, both Left and Right, Synthes GmbH (HSA 600:41/01-002/16/11_46) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-11_46 FSN [PDF, 2830 KB] (opens in new tab)
28 Mar 2016	DiaMed Diaclon Anti-N, DiaMed GmbH (HSA 600:41/01-027/16/03_22) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262	HSA 6004101-027-16-03_22 FSN [PDF, 215 KB] (opens in new tab)
28 Mar 2016	Biolox Delta Revision Head 12/14 32mm S, Aesculap AG (HSA 600:41/01-012/16/03_43) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-16-03_43 FSN [PDF, 213 KB] (opens in new tab)
28 Mar 2016	Antimicrobial Susceptibility Test disc Ticarcillin/Clavulanic Acid, Oxoid Limited (HSA 600:41/01-178/16/02_23) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999992	HSA 6004101-178-16-02_23 FSN [PDF, 116 KB] (opens in new tab)
24 Mar 2016	Symbia E and e.cam collimator, Siemens Medical Solutions USA Inc (HSA 600:41/01-022/16/13_63) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-13_63 FSN [PDF, 2223 KB] (opens in new tab)
24 Mar 2016	R3 MULTI HOLE ACETABULAR SHELL, Smith & Nephew Inc (HSA 600:41/01-073/16/11_51) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-11_51 FSN [PDF, 199 KB] (opens in new tab)
24 Mar 2016	E.cam and all Symbia systems with foresight detectors, Siemens Medical Solutions USA Inc (HSA 600:41/01-022/16/11_41) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-11_41 FSN [PDF, 291 KB] (opens in new tab)
24 Mar 2016	Syngo X-Workplace, Siemens Healthcare GmbH (HSA 600:41/01-022/16/12_50) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-12_50 FSN [PDF, 1468 KB] (opens in new tab)
23 Mar 2016	Dimension, Dimension Vista, ADVIA Chemistry Systems Assays, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/10_20) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: 64907374	HSA 6004101-022-16-10_20 FSN [PDF, 78 KB] (opens in new tab) HSA 6004101-022-16-10_20 FSN [PDF, 79 KB] (opens in new tab)
22 Mar 2016	BD Retic-Count™ Reagent, Becton, Dickinson and Company (HSA 600:41/01-003/16/02_60) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 64322048	HSA 6004101-003-16-02_60 FSN [PDF, 28 KB] (opens in new tab)
22 Mar 2016	SYNERGY TITANIUM PRESSFIT Femoral Component, Smith & Nephew Inc (HSA 600:41/01-073/16/10_44) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-10_44 FSN [PDF, 79 KB] (opens in new tab)
22 Mar 2016	Rotem Sigma Complete and Rotem Sigma Complete + Hep Cartridge, TEM International GmbH (HSA 600:41/01-118/16/01_61) Local Contact: Unimed Healthcare Pte Ltd Contact no./Email: enquiry@unimed.com.sg	HSA 6004101-118-16-01_61 FSN [PDF, 269 KB] (opens in new tab)
22 Mar 2016	Dialog+ Dialyzer Machine, B. Braun Avitum AG (HSA 600:41/01-012/16/02_36) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130941	HSA 6004101-012-16-02_36 FSN [PDF, 66 KB] (opens in new tab)
22 Mar 2016	Fred Easyport Automated External Defibrilator, Schiller AG (HSA 600:41/01-056/16/04_40) Local Contact: Gold Lite Pte Ltd Contact no./Email: 62730487	HSA 6004101-056-16-04_40 FSN [PDF, 158 KB] (opens in new tab)
21 Mar 2016	PENTAX Medical ED-3490TK Video Duodenoscope, Hoya Corporation (HSA 600:41/01-106/16/01_49) Local Contact: Pentax Medical Singapore Pte Ltd Contact no./Email: vigilanceAsia@pentaxmedical.com	HSA 6004101-106-16-01_49 FSN [PDF, 90 KB] (opens in new tab)
18 Mar 2016	VA-LCP Dorsal Distal Radius L-Plate, Synthes GmbH (HSA 600:41/01-002/16/10_45) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-10_45 FSN [PDF, 71 KB] (opens in new tab)
18 Mar 2016	Persona PS Articular Surfaces, Zimmer Inc (HSA 600:41/01-008/16/05_35) Local Contact: Zimmer Pte Ltd Contact no./Email: 68547222	HSA 6004101-008-16-05_35 FSN [PDF, 346 KB] (opens in new tab)
18 Mar 2016	TruLab controls and TruCal U calibrator, Diasys Diagnostics Systems GmbH (HSA 600:41/01-032/16/03_59) Local Contact: Sysmex Asia Pacific Pte Ltd Contact no./Email: RA@sysmex‐ap.com	HSA 6004101-032-16-03_59 FSN [PDF, 2437 KB] (opens in new tab)
17 Mar 2016	ACCUFORCE® PTCA Dilatation Catheter, Terumo Corporation (HSA 600:41/01-028/16/02_18) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 62913603	HSA 6004101-028-16-02_18 FSN [PDF, 172 KB] (opens in new tab)
17 Mar 2016	Pressure Regulator, Omrix Biopharmaceuticals Ltd (HSA 600:41/01-002/16/09_17) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-09_17 FSN [PDF, 61 KB] (opens in new tab)
17 Mar 2016	Hamilton-G5, Hamilton Medical AG (HSA 600:41/01-248/16/01_56) Local Contact: MeDeus (S) Pte Ltd Contact no./Email: 62769982	HSA 6004101-248-16-01_56 FSN [PDF, 974 KB] (opens in new tab)
16 Mar 2016	QuantiFERON®-TB Gold TB-Antigen blood collection tubes, Cellestis (HSA 600:41/01-179/16/01_57) Local Contact: QIAGEN Singapore Pte Ltd Contact no./Email: 68548100	HSA 6004101-179-16-01_57 FSN [PDF, 39 KB] (opens in new tab)
15 Mar 2016	TF Adaptive Gutta Percha Point Size SM3-50 pk, SybronEndo (HSA 600:41/01-168/16/01_48) Local Contact: Kavo Dental Supply Contact no./Email: 62961790	HSA 6004101-168-16-01_48 FSN [PDF, 375 KB] (opens in new tab)
15 Mar 2016	GE Signa Pioneer MRI System, GE Healthcare Japan Corporation (HSA 600:41/01-010/16/04_33) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668	HSA 6004101-010-16-04_33 FSN [PDF, 79 KB] (opens in new tab)
14 Mar 2016	Cranial Screw PlusDrive, Johnson & Johnson Pte Ltd (HSA 600:41/01-002/16/08_46) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276459	HSA 6004101-002-16-08_46 FSN [PDF, 119 KB] (opens in new tab)
11 Mar 2016	Freelite Human Kappa Integra Kit, The Binding Site Group Ltd (HSA 600:41/01-293/16/01_38) Local Contact: The Binding Site Group Ltd Contact no./Email: 6906 0596	HSA 6004101-293-16-01_38 FSN [PDF, 1163 KB] (opens in new tab)
11 Mar 2016	da Vinci Xi Surgical System and da Vinci Si Surgical System, Intuitive Surgical Inc (HSA 600:41/01-070/16/08_54) Local Contact: Transmedic Pte Ltd Contact no./Email: 64776101	HSA 6004101-070-16-08_54 FSN [PDF, 136 KB] (opens in new tab)
10 Mar 2016	Instinct Java System Instruments, Universal Clamp System Instruments, UniWallis System Instruments, Zimmer Spine (HSA 600:41/01-008/16/04_63) Local Contact: Zimmer Pte Ltd Contact no./Email: 68547222	HSA 6004101-008-16-04_63 FSN [PDF, 301 KB] (opens in new tab)
09 Mar 2016	i-STAT® cTnI cartridge, Abbott Point of Care Inc. (HSA 600:41/01-070/16/07_31) Local Contact: Transmedic Pte Ltd Contact no./Email: 64776101	HSA 6004101-070-16-07_31 FSN [PDF, 22 KB] (opens in new tab)
09 Mar 2016	Medivance ARCTICGEL Pads, C.R. Bard, Inc. (HSA 600:41/01-050/16/02_41) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 65805988	HSA 6004101-050-16-02_41 FSN [PDF, 510 KB] (opens in new tab)
09 Mar 2016	Elecsys Estradiol II assay, Elecsys Estradiol III assay, Roche Diagnostics GmbH (HSA 600:41/01-016/16/03_34) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-03_34 FSN [PDF, 90 KB] (opens in new tab)
08 Mar 2016	Analyst MD Software - Component of API 3200MD LC/MS/MS System, 3200MD QTRAP LC/MS/MS System, Triple Quad 4500MD LC/MS/MS System, and QTRAP 4500MD LC/MS/MS System, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/01_24) Local Contact: AB SCIEX Pte Ltd Contact no./Email: 63043722	HSA 6004101-255-16-01_24 FSN [PDF, 120 KB] (opens in new tab)
07 Mar 2016	VERION Reference Unit (Vision Planner), WaveLight GmbH (HSA 600:41/01-135/16/01_35) Local Contact: Alcon Pte Ltd Contact no./Email: 67221255	HSA 6004101-135-16-01_35 FSN [PDF, 1124 KB] (opens in new tab)
07 Mar 2016	TOPAZ™ MicroDebrider, ArthroCare Corporation (HSA 600:41/01-073/16/09_49) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-09_49 FSN [PDF, 72 KB] (opens in new tab)
07 Mar 2016	Keymed Olympus KV-5 Suction Pump – Patient Connecting Tube MAJ-103, KeyMed (Medical & Industrial Equipment) Ltd (HSA 600:41/01-004/16/02_44) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: 6833 4219	HSA 6004101-004-16-02_44 FSN [PDF, 4515 KB] (opens in new tab)
04 Mar 2016	Laseredge 2.0mm x 2.2mm Trapezoidal Angled Knife with Handle, Bausch & Lomb, Incorporated (HSA 600:41/01-030/16/01_37) Local Contact: Bausch & Lomb (Singapore) Pte Ltd Contact no./Email: 68349112	HSA 6004101-030-16-01_37 FSN [PDF, 2454 KB] (opens in new tab)
03 Mar 2016	CA500 Epix Universal Clip Applier, Applied Medical Distribution Corporation (HSA 600:41/01-163/16/01_45) Local Contact: Ikon Medical Pte Ltd Contact no./Email: medicaldevice.services11@gmail.com	HSA 6004101-163-16-01_45 FSN [PDF, 359 KB] (opens in new tab)
03 Mar 2016	CEA / CD66e Ab-2, Thermo Scientific (HSA 600:41/01-285/16/01_22) Local Contact: Fisher Scientific Pte Ltd Contact no./Email: 68736006	HSA 6004101-285-16-01_22 FSN [PDF, 399 KB] (opens in new tab)
01 Mar 2016	HemoCue Glucose 201 RT Microcuvettes, HemoCue AB (HSA 600:41/01-070/16/06_20) Local Contact: Transmedic Pte Ltd Contact no./Email: 64776101	HSA 6004101-070-16-06_20 FSN [PDF, 159 KB] (opens in new tab)
01 Mar 2016	Shuttle Select Slip-Cath Catheter, Cook Incorporated (HSA 600:41/01-013/16/02_29) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 62877888	HSA 6004101-013-16-02_29 FSN [PDF, 177 KB] (opens in new tab)
01 Mar 2016	MCS+/LDP W/Filter; CONC PLT & PLS Set W/Filter; PBSC Set (225mL Latham), Haemonetics Corporation (HSA 600:41/01-070/16/05_19) Local Contact: Transmedic Pte Ltd Contact no./Email: 64776101	HSA 6004101-070-16-05_19 FSN [PDF, 347 KB] (opens in new tab)