Field Safety Notices
Field Safety Notice - Dec 2015
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 December 2015
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DATE OF | TITLE | FSN |
|---|---|---|
30 Dec 2015 | VerifyNow Aspirin Test Kits, Accumetrics Inc (HSA 600:41/01-246/15/01_34) | |
30 Dec 2015 | CardioCall ECG Event Recorder, Spacelabs Healthcare Ltd (HSA 600:41/01-029/15/02_44) | |
30 Dec 2015 | Mavig Monitor suspensions installed on INNOVA 2000, INNOVA X100/IQ, INNOVA X1X1IQ, Advantx LCV+, Advantx LCA, Advantx LCLP+, Advantx LCN+ fluoroscopic imaging systems, GE Medical Systems SCS (HSA 600:41/01-010/15/25_52) | |
30 Dec 2015 | Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems, GE Medical Systems LLC (HSA 600:41/01-010/15/24_43) | |
29 Dec 2015 | Concerto Basic Shower Trolley, ArjoHuntleigh AB (HSA 600:41/01-065/15/01_51) | |
28 Dec 2015 | Multiple dental abutment products and accessories, Biomet 3i (HSA 600:41/01-181/15/03_35) | |
28 Dec 2015 | Nucleotron MicroSelection V3 remote controlled radionuclide applicator system, Nucletron B.V. (HSA 600:41/01-101/15/11_40) | |
28 Dec 2015 | MOSAIQ, IMPAC Medical System Inc (HSA 600:41/01-101/15/10_36) | |
28 Dec 2015 | Drive Gas Check Valve used with Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices, Datex-Ohmeda Inc (HSA 600:41/01-010/15/23_41) | |
24 Dec 2015 | Battery Power Line II Battery Oscillator, Synthes GmbH (HSA 600:41/01-002/15/62_37) | |
24 Dec 2015 | Syngo Plaza, Siemens AG (HSA 600:41/01-022/15/64_25) | |
24 Dec 2015 | D10 Rack Loader, Bio-Rad Laboratories Inc (HSA 600:41/01-027/15/06_24) | |
24 Dec 2015 | Antimicrobial Susceptibility Testing Disc - QD15 Quiupristin/Dalfopristin, Oxoid Limited (HSA 600:41/01-178/15/06_31) | |
22 Dec 2015 | Nova T Copper Intrauterine Device, Bayer Pharma AG (HSA 600:41/01-066/15/01_48) | |
22 Dec 2015 | miraDry System, Miramar Labs Inc (HSA 600:41/01-119/15/03_56) | |
21 Dec 2015 | SYNTHES® Universal Tibial and Femoral Nail System, Synthes GmbH (HSA 600:41/01-002/15/60_46) | |
21 Dec 2015 | VITROS 250, VITROS 350, VITROS 5,1 FS, VITROS 4600 & VITROS 5600, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/61_22) | |
21 Dec 2015 | Allura Xper FD20 X-Ray Imaging System, Philips Medical Systems Nederland BV (HSA 600:41/01-026/15/42_55) | |
18 Dec 2015 | Datascope Cardiosave™ Intra-Aortic Balloon Pump, Datascope Corp (HSA 600:41/01-017/15/12_54) | |
17 Dec 2015 | neXtra® Cutter Shaver Blades, DePuy Mitek (HSA 600:41/01-002/15/59_41) | |
17 Dec 2015 | Certofix Quattro, B Braun Melsungen AG (HSA 600:41/01-012/15/10_51) | |
17 Dec 2015 | Titanium Fluted Stem Extender, Howmedica Osteonics Corp (HSA 600:41/01-014/15/14_45) | |
17 Dec 2015 | Dengue NS1 Ag Strip, Bio-Rad Laboratories (HSA 600:41/01-027/15/05_20) | |
17 Dec 2015 | Oxylog 3000, 3000 plus & 2000 plus, Draegerwerk AG & Co KGaA (HSA 600:41/01-063/15/05_52) | |
16 Dec 2015 | ArmeoPower, Hocoma AG (HSA 600:41/01-286/15/01_35) | HSA 6004101-286-15-01_35 FSN [PDF, 136 KB] HSA 6004101-286-15-01_35 FSN [PDF, 129 KB] |
16 Dec 2015 | Perseus A500 Anesthesia Workstation, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/15/04_40) | |
16 Dec 2015 | Magnetom MR Systems and Biograph mMR, Siemens AG (for all MR systems except Magnetom Essenza); Siemens Shenzhen Magnetic Resonance Ltd (for Magnetom Essenza) (HSA 600:41/01-022/15/63_37) | |
16 Dec 2015 | Discovery MR750w; Discovery MR750, GE Medical Systems LLC (HSA 600:41/01-010/15/22_36) | |
16 Dec 2015 | PFNA, PFNA-II, DFN, & PFN Nails, PFNA & PFNA-II Blades, and PFNA & PFNA-II End Cap Extensions, Synthes GmbH (HSA 600:41/01-002/15/58_49) | |
15 Dec 2015 | Samarys Peek Anterior Cervical Cage, Scient'x SAS (HSA 600:41/01-198/15/01_33) | |
14 Dec 2015 | Osteo-Site® Murphy Side Bevel Bone Biopsy Needle Set, Cook Incorporated(HSA 600:41/01-013/15/07_54) | |
14 Dec 2015 | EchoTip® Ultra Endobronchial High Definition Ultrasound Needles, Cook Ireland Ltd (HSA 600:41/01-013/15/08_46) | |
14 Dec 2015 | Soluscope Serie 4 PA, Soluscope SAS (HSA 600:41/01-017/15/10_56) | |
14 Dec 2015 | Maquet FLOW-i Anesthesia System, Maquet Critical Care AB (HSA 600:41/01-017/15/11_29) | |
14 Dec 2015 | Ambu AurGain Single Use Laryngeal Mask, Ambu A/S (HSA 600:41/01-056/15/03_45) | |
14 Dec 2015 | Source Administration Sets (SAS), Bayer Medical Care (HSA 600:41/01-069/15/02_55) | |
14 Dec 2015 | Arcadophta ® ARCOTANE C8F18 Purified Perfluoro-n-octane for Retinal Surgery, Arcadophta (HSA 600:41/01-104/15/01_18) | |
14 Dec 2015 | GlideScope Reusable GVL and AVL Blades, Verathon Medical Inc (HSA 600:41/01-076/16/03_43) | |
10 Dec 2015 | Synthes SynReam Medullary Reamer Head 13.5mm, Mathys Medical Ltd (HSA 600:41/01-002/15/57_53) | |
08 Dec 2015 | Terumo® Destination® Renal Guiding Sheath, Terumo Medical Corporation (HSA 600:41/01-028/15/01_44) | |
08 Dec 2015 | da Vinci Xi Endoscope with Camera, 8mm, 0 deg and 30 deg, Intuitive Surgical (HSA 600:41/01-070/15/22_52) | |
07 Dec 2015 | Beckman Coulter Unicel DxH 600 and 800 Coulter Cellular Analysis System, Beckman Coulter Inc. (HSA 600:41/01-052/15/11_61)| | |
07 Dec 2015 | PuraStat, 3-D Matrix Europe SAS (HSA 600:41/01-282/15/02_51) | |
07 Dec 2015 | Absorb Bioresorbable Vascular Scaffold System and Absorb GT1 Bioresorbable Vascular Scaffold System, Abbott Vascular (HSA 600:41/01-005/15/06_43) | |
07 Dec 2015 | Endo GIA Ultra Universal Stapler Handles, Covidien llc (HSA 600:41/01-046/15/09_41) | |
07 Dec 2015 | Masimo Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet, Masimo Corporation (HSA 600:41/01-061/15/01_50) | |
04 Dec 2015 | PFN/PFNA Insertion Handle, Synthes GmbH (HSA 600:41/01-002/15/55_49) | |
04 Dec 2015 | ADVIA 1200/1800/2400 Chemistry Systems, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/15/62_60) | |
04 Dec 2015 | Kirschner Wire 1.6mm w/Drill Tip, L 200mm, sterile, Synthes GmbH (HSA 600:41/01-002/15/56_36) | |
03 Dec 2015 | GYNECARE THERMACHOICE™ III Thermal Balloon Ablation Silicone Catheter, Ethicon, Inc. (HSA 600:41/01-002/15/54_33) | |
03 Dec 2015 | Cellistypt, Cellistypt D-K and Cellistypt F, Synthesia, a.s. (HSA 600:41/01-012/15/09_37) | |
02 Dec 2015 | Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT SP, Brilliance iCT, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/15/41_19) | |
02 Dec 2015 | Olympus Endoeye HD II, Olympus Winter & Ibe GmbH (HSA 600:41/01-004/15/07_29) | |
01 Dec 2015 | Cytoluer Set, Baxter Healthcare SA, (HSA 600:41/01-001/15/04_25) | |
01 Dec 2015 | Bond Polymer Refine Red Detection, Leica Biosystems Newcastle Ltd (HSA 600:41/01-126/15/05_59) |