Field Safety Notices
Field Safety Notice - Dec 2017
31 December 2017
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Dec 2017 | ADVIA Centaur CP, XP, XPT BNP and TSH3-UL assay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/34_23) | HSA 6004101-022-17-34_23 FSN [PDF, 100 KB] (opens in new tab) |
29 Dec 2017 | W & H Implantmed Surgical Drive Unit, W & H Dentalwerk Burmoos GmbH (HSA 600:41/01-164/17/01_52) | HSA 6004101-164-17-01_52 FSN [PDF, 91 KB] (opens in new tab) |
29 Dec 2017 | Cook Transseptal Needle, Cook Incorporated (HSA 600:41/01-013/17/11_62) | HSA 6004101-013-17-11_62 FSN_Redacted [PDF, 1118 KB] (opens in new tab) |
29 Dec 2017 | Cook Guardia Access Nano Embryo Transfer Catheter, Cook Incorporated (HSA 600:41/01-013/17/10_52) | HSA 6004101-013-17-10_52 FSN_Redacted [PDF, 108 KB] (opens in new tab) |
28 Dec 2017 | ROCHE COBAS U 601 URINE ANALYZER and ROCHE COBAS U 701 MICROSCOPY ANALYZER, Roche Diagnostics GmbH (HSA 600:41/01-016/17/21_57) | HSA 6004101-016-17-21_57 FSN [PDF, 559 KB] (opens in new tab) |
28 Dec 2017 | Phadia ImmunoCAP Specific IgE Fluoreenzyme immunoassay, Phadia AB (HSA 600:41/01-033/17/05_70) | HSA 6004101-033-17-05_70 FSN_Redacted [PDF, 279 KB] (opens in new tab) |
26 Dec 2017 | LIFEPAK 20e, Physio-Control, Inc (HSA 600:41/01-056/17/07_51) | HSA 6004101-056-17-07_51 HSN_Redacted [PDF, 433 KB] (opens in new tab) |
22 Dec 2017 | ARROW AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT, Arrow International, Inc (HSA 600:41/01-139/17/06_49) | HSA 6004101-139-17-06_49 FSN [PDF, 49 KB] (opens in new tab) |
22 Dec 2017 | GUIDER SOFTIP™ XF GUIDE CATHETERS, Boston Scientific Corporation (HSA 600:41/01-070/17/26_49) | HSA 6004101-070-17-26_49 FSN [PDF, 277 KB] (opens in new tab) |
22 Dec 2017 | LigaSure Maryland Jaw Sealer/Dividers, Covidien llc (HSA 600:41/01-046/17/12_50) | HSA 6004101-046-17-12_50 FSN_Redacted [PDF, 1866 KB] (opens in new tab) |
22 Dec 2017 | Hemoglobin A1c (HbA1c) Reagent Kit, Abbott Laboratories (HSA 600:41/01-005/17/28_69) | HSA 6004101-005-17-28_69 FSN [PDF, 220 KB] (opens in new tab) |
21 Dec 2017 | Allura Xper systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/17/21_56) | HSA 6004101-026-17-21_56 FSN_Redacted [PDF, 449 KB] (opens in new tab) |
21 Dec 2017 | CARESCAPE R860 ventilator, Datex-Ohmeda Inc (HSA 600:41/01-010/17/07_35) | HSA 6004101-010-17-07_35 FSN_Redacted [PDF, 286 KB] (opens in new tab) |
21 Dec 2017 | 2.7MM S-T CORTEX SCREW 16MM, Smith & Nephew, Inc. (HSA 600:41/01-073/17/20_56) | HSA 6004101-073-17-20_56 FSN [PDF, 174 KB] (opens in new tab) |
21 Dec 2017 | ELECSYS BRAHMS PCT, Roche Diagnostics GmbH (HSA 600:41/01-016/17/19_69) | HSA 6004101-016-17-19_69 FSN [PDF, 340 KB] (opens in new tab) |
21 Dec 2017 | Hematoxylin II and Horseradish Peroxidase reagents (refer FSN for affected Kits name), Ventana Medical Systems, Inc. (HSA 600:41/01-016/17/20_38) | HSA 6004101-016-17-20_38 FSN [PDF, 465 KB] (opens in new tab) |
21 Dec 2017 | Philips CORE, and CORE Mobile systems with software version v3.5, Volcano Corporation (HSA 600:41/01-070/17/25_68) | HSA 6004101-070-17-25_68 FSN_Redacted [PDF, 1233 KB] (opens in new tab) |
21 Dec 2017 | Lullaby RESUS Plus Systems, Ohmeda Medical (HSA 600:41/01-010/17/06_71) | HSA 6004101-010-17-06_71 FSN_Redacted [PDF, 514 KB] (opens in new tab) |
20 Dec 2017 | SpyScope DS Access and Delivery Catheter, Boston Scientific Corporation (HSA 600:41/01-007/17/15_54) | HSA 6004101-007-17-15_54 FSN_Redacted [PDF, 1667 KB] (opens in new tab) |
20 Dec 2017 | BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16 | HSA 6004101-026-17-20_46 FSN_Redacted [PDF, 307 KB] (opens in new tab) |
20 Dec 2017 | Cardiac Resynchronization Therapy pacemakers (VALITUDE™, VISIONIST™) and defibrillators (CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™) | HSA 6004101-007-17-14_43 FSN_Redacted [PDF, 946 KB] (opens in new tab) |
20 Dec 2017 | Taylor Spatial Frame Website Software, Smith & Nephew, Inc. (HSA 600:41/01-073/17/19_52) | HSA 6004101-073-17-19_52 FSN_Redacted [PDF, 200 KB] (opens in new tab) |
19 Dec 2017 | ClearSight Heart Reference Sensor, Edwards Lifesciences (HSA 600:41/01-060/17/02_50) | HSA 6004101-060-17-02_50 FSN_Redacted [PDF, 2463 KB] (opens in new tab) |
19 Dec 2017 | PACEMAKERS (ACCOLADE™, PROPONENT™, ESSENTIO™, ALTRUA™ 2), CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (VALITUDE™, VISIONIST™) | HSA 6004101-007-17-13_51 FSN_Redacted [PDF, 409 KB] (opens in new tab) |
19 Dec 2017 | Boston Scientific Uphold LITE Vaginal Support System & Boston Scientific Solyx SIS System, Boston Scientific Corporation (HSA 600:41/01-007/17/12_18) | HSA 6004101-007-17-12_18 FSN_Redacted [PDF, 312 KB] (opens in new tab) |
19 Dec 2017 | Atellica UAS 800 analyzer, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/17/33_34) | HSA 6004101-022-17-33_34 FSN [PDF, 35 KB] (opens in new tab) |
19 Dec 2017 | UNIVERSAL WEDGE SCREW, 9MM X 25MM | HSA 6004101-014-17-08_54 FSN_Redacted [PDF, 138 KB] (opens in new tab) |
19 Dec 2017 | Covidien Signia Power Handles, Covidien llc (HSA 600:41/01-046/17/11_63) | HSA 6004101-046-17-11_63 FSN_Redacted [PDF, 2092 KB] (opens in new tab) |
19 Dec 2017 | Trevo XP Provue Procedure Pack, Concentric Medical, Inc (HSA 600:41/01-070/17/24_71) | HSA 6004101-070-17-24_71 FSN [PDF, 141 KB] (opens in new tab) |
19 Dec 2017 | IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/17/32_31) | HSA 6004101-022-17-32_31 FSN [PDF, 88 KB] (opens in new tab) |
18 Dec 2017 | Abbott CELL-DYN Emerald 22 Instrument, Abbott Laboratories Diagnostics Division (HSA 600:41/01-005/17/27_34) | HSA 6004101-005-17-27_34 FSN [PDF, 96 KB] (opens in new tab) |
18 Dec 2017 | Trevo XP Provue System, TREVO XP PROVUE RETRIEVER 4X20 + TREVO PRO 18 MC KIT, Concentric Medical, Inc (HSA 600:41/01-070/17/23_46) | HSA 6004101-070-17-23_46 FSN [PDF, 37 KB] (opens in new tab) |
18 Dec 2017 | Cordis SMART Flex Vascular Stent System, Cordis Cashel (HSA 600:41/01-307/17/02_50) | HSA 6004101-307-17-02_50 FSN_Redacted [PDF, 302 KB] (opens in new tab) |
15 Dec 2017 | Abbott Architect DHEA-S Assay, Abbott GmbH & Co. KG (HSA-600-41/01-005/17/26_70) | HSA 6004101-005-17-26_70 FSN [PDF, 205 KB] (opens in new tab) |
14 Dec 2017 | ETEST® Teicoplanin 256 (TP) SPB and Foam packaging, BioMerieux S.A (HSA 600:41/01-146/17/13_69) | HSA 6004101-146-17-13_69 FSN [PDF, 452 KB] (opens in new tab) |
13 Dec 2017 | CUTICERIN Surgical Dressing, Smith & Nephew Medical Limited (HSA 600:41/01-073/17/18_48) | HSA 6004101-073-17-18_48 FSN [PDF, 118 KB] (opens in new tab) |
13 Dec 2017 | Artis Zee and Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/31_44) | HSA 6004101-022-17-31_44 FSN_Redacted [PDF, 121 KB] (opens in new tab) |
13 Dec 2017 | Bone Cement and Optipac, Biomet France (HSA 600:41/01-008/17/20_63) | HSA 6004101-008-17-20_63 FSN_Redacted [PDF, 342 KB] (opens in new tab) |
13 Dec 2017 | Persona Stemmed Tibial Plate, Zimmer Inc. (HSA 600:41/01-008/17/19_51) | HSA 6004101-008-17-19_51 FSN_Redacted [PDF, 66 KB] (opens in new tab) |
13 Dec 2017 | Philips Ingenuity TF PET/CT Imaging System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/17/19_44) | HSA 6004101-026-17-19_44 FSN_Redacted [PDF, 606 KB] (opens in new tab) |
13 Dec 2017 | da Vinci Xi EndoWrist Stapler 45, 30, 30 curved tip, Intuitive Surgical Inc. (HSA 600:41/01-070/17/22_36) | HSA 6004101-070-17-22_36 FSN [PDF, 470 KB] (opens in new tab) |
12 Dec 2017 | Malecot Nephrostomy Catheter Set and Re-Entry™ Malecot Nephrostomy Catheter Set, Boston Scientific Corporation (HSA 600:41/01-007/17/11_49) | HSA 6004101-007-17-11_49 FSN_Redacted [PDF, 155 KB] (opens in new tab) |
12 Dec 2017 | Proteus 235, Ion Beam Applications S.A. (HSA 600:41/01-070/17/21_64) | HSA 6004101-070-17-21_64 FSN2_Redacted [PDF, 1339 KB] (opens in new tab) |
11 Dec 2017 | ARCHITECT C4000 CUVETTE SEGMENT ARCHITECT, C8000 CUVETTE SEGMENT, ARCHITECT C16000 CUVETTE SEGMENT, Abbott Laboratories (HSA 600:41/01-005/17/25_67) | HSA 6004101-005-17-25_67 FSN [PDF, 405 KB] (opens in new tab) |
08 Dec 2017 | Alaris Syringe Module Model 8110 and Alaris PCA Module Model 8120, CareFusion 303 Inc (HSA 600:41/01-003/17/21_35) | HSA 6004101-003-17-21_35 FSN_Redacted [PDF, 1748 KB] (opens in new tab) |
08 Dec 2017 | Aquagel 5gms, Ecolab Ltd (HSA 600:41/01-318/17/01_35) | HSA 6004101-318-17-01_35 FSN_Redacted [PDF, 134 KB] (opens in new tab) |
07 Dec 2017 | 1•DAY ACUVUE® MOIST™ Brand, Johnson & Johnson Vision Care Inc (HSA 600:41/01-002/17/15_37) | HSA 6004101-002-17-15_37 FSN_Redacted [PDF, 1439 KB] (opens in new tab) |
07 Dec 2017 | 1.0MM DRILL BIT MINI-QUICK CONNECT and FAST 1.1MM DRILLBIT MINIQUICK, Biomet Orthopaedics (HSA 600:41/01-008/17/18_37) | HSA 6004101-008-17-18_37 FSN_Redacted [PDF, 84 KB] (opens in new tab) |
06 Dec 2017 | Respironics Bipap A40, Respironics Inc. (HSA 600:41/01-199/17/01_71) | HSA 6004101-199-17-01_71 FSN_Redacted [PDF, 184 KB] (opens in new tab) |
06 Dec 2017 | Various highly polished hip and knee implants, Zimmer, Inc. (HSA 600:41/01-008/17/17_18) | HSA 6004101-008-17-17_18 FSN_Redacted [PDF, 758 KB] (opens in new tab) |
06 Dec 2017 | Automated Digital Cell Morphology Analyzer DI-60, CellaVision AB (HSA 600:41/01-032/17/06_31) | HSA 6004101-032-17-06_31 FSN_Redacted [PDF, 1829 KB] (opens in new tab) |
06 Dec 2017 | Elekta Synergy, Elekta Synergy S, Elekta Infinity, Elekta Axxesse, Elekta VersaHD, Elekta Limited (HSA 600:41/01-101/17/10_19) | HSA 6004101-101-17-10_19 FSN 1_Redacted [PDF, 459 KB] (opens in new tab) |
06 Dec 2017 | MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7, MAKO Surgical Corp (HSA 600:41/01-070/17/20_64) | HSA 6004101-070-17-20_64 FSN [PDF, 98 KB] (opens in new tab) |
05 Dec 2017 | Qisda InnoSight Diagnostic Ultrasound System, QISDA Corporation (HSA 600:41/01-026/17/18_52) | HSA 6004101-026-17-18_52 FSN_Redacted [PDF, 31 KB] (opens in new tab) |
04 Dec 2017 | Boston Scientific Wallstent Endoprostheses with Unistep Plus Delivery System, Boston Scientific Corporation (HSA 600:41/01-007/17/10_40) | HSA 6004101-007-17-10_40 FSN_Redacted [PDF, 795 KB] (opens in new tab) |
04 Dec 2017 | ARROW® CVC, MAC, PI CVC, PICC, and PSI Kits, Arrow International, Inc (HSA 600:41/01-139/17/05_48) | HSA 6004101-139-17-05_48 FSN [PDF, 27 KB] (opens in new tab) |
01 Dec 2017 | Thermo Scientific Oxoid Brilliance Staph 24, Oxoid Limited (HSA 600:41/01-178/17/08_61) | HSA 6004101-178-17-08_61 FSN_Redacted [PDF, 153 KB] (opens in new tab) |
01 Dec 2017 | Cook Vital-Port® Vascular Access System, Cook Medical (HSA 600:41/01-013/17/09_49) | HSA 6004101-013-17-09_49 FSN_Redacted [PDF, 64 KB] (opens in new tab) |
05 Oct 2017 | Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/08_58) | HSA 6004101-027-17-08_58 FSN update_Redacted [PDF, 2470 KB] (opens in new tab) |