Field Safety Notices
Field Safety Notice - Sep 2017
Audiences
Healthcare professional
Industry member
Product type
Medical devices
30 September 2017
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Sep 2017 | Draeger Infinity MCable Dual Hemo Pod, Draeger Medical Systems Inc (HSA 600:41/01-063/17/04_52) | HSA 6004101-063-17-04_52 FSN_Redacted [PDF, 1312 KB] (opens in new tab) |
28 Sep 2017 | BARD ® MAX-CORE ® Disposable Core Biopsy Instrument, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/17/02_18) | HSA 6004101-050-17-02_18 FSN_Redacted [PDF, 249 KB] (opens in new tab) |
28 Sep 2017 | Legion Screw-on Wedge Size 4, Smith & Nephew Inc. (HSA 600:41/01-073/17/13_40) | HSA 6004101-073-17-13_40 FSN [PDF, 173 KB] (opens in new tab) |
28 Sep 2017 | Elekta ERGO++ RTP Software, IMPAC Inc (HSA 600:41/01-101/17/08_64) | HSA 6004101-101-17-08_64 FSN [PDF, 1166 KB] (opens in new tab) |
28 Sep 2017 | VICRYL RAPIDE™ (POLYGLACTIN 910) SUTURE, Ethicon LLC, Johnson & Johnson Pte Ltd (HSA 600:41/01-002/17/11_19) | HSA 6004101-002-17-11_19 FSN_Redacted [PDF, 215 KB] (opens in new tab) |
27 Sep 2017 | LENTIS IOL, Oculentis B.V. (HSA 600:41/01-261/17/01_62) | HSA 6004101-261-17-01_62 FSN_Redacted [PDF, 7676 KB] (opens in new tab) |
27 Sep 2017 | Smart HIV 1/2 RPT Device, Cell ID Pte Ltd (HSA 600:41/01-316/17/01_38) | HSA 6004101-316-17-01_38 FSN_Redacted [PDF, 595 KB] (opens in new tab) |
26 Sep 2017 | Hill-Rom Progressa Bed System, Hill-Rom, Inc. (HSA 600:41/01-017/17/04_48) | HSA 6004101-017-17-04_48 FSN [PDF, 615 KB] (opens in new tab) |
26 Sep 2017 | DCA Barcode Reader Kit for DCA Vantage Analyzer and CLINITEK Status Connect System, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/28_23) | HSA 6004101-022-17-28_23 FSN [PDF, 217 KB] (opens in new tab) |
26 Sep 2017 | Bio-Rad Antiserum Salmonella Monovalent H Antisera H:z, Bio-Rad Antiserum Salmonella Monovalent H Antisera H:x, Bio-Rad Antiserum Salmonella Polyvalent H Antisera HMB (e,h+e,n,x+e,n,z15+G), Bio-Rad Antiserum Salmonella Polyvalent H A, Bio-Rad Laboratories (HSA 600:41/01-027/17-06_65) | HSA 6004101-027-17-06_65 FSN [PDF, 70 KB] (opens in new tab) |
22 Sep 2017 | Covidien GastriSail™ Gastric Positioning System, Covidien llc (HSA 600:41/01-046/17/08_56) | HSA 6004101-046-17-08_56 FSN_Redacted [PDF, 1624 KB] (opens in new tab) |
21 Sep 2017 | Hill-Rom Progressa Bed System, Hill-Rom, Inc. (HSA 600:41/01-182/17/01_48) | HSA 6004101-182-17-01_48 FSN [PDF, 237 KB] (opens in new tab) |
21 Sep 2017 | VITROS Chemistry Products DAT Performance Verifiers, Ortho- Clinical Diagnostics Inc (HSA 600:41/01-303/17/11_31) | HSA 6004101-303-17-11_31 FSN_Redacted [PDF, 3083 KB] (opens in new tab) |
20 Sep 2017 | Artis Zee and Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/27_46) | HSA 6004101-022-17-27_46 FSN_Redacted [PDF, 232 KB] (opens in new tab) |
20 Sep 2017 | DELTA XTEND™ Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants, Depuy France S.A.S (HSA 600:41/01-002/17/10_43) | HSA 6004101-002-17-10_43 FSN_Redacted [PDF, 219 KB] (opens in new tab) |
20 Sep 2017 | Philips SureSigns VSi Vital Signs Monitor, Philips SureSigns VS2+ Vital Signs Monitor, Philips Medical Systems (HSA 600:41/01-026/17/16_56) | HSA 6004101-026-17-16_56 FSN_Redacted [PDF, 34 KB] (opens in new tab) |
19 Sep 2017 | Neuray Surgical Patties And Strips, Merocel Neurosurgical Patties And Packing, Medtronic Xomed (HSA 600:41/01-009/17/19_63) | HSA 6004101-009-17-19_63 FSN_Redacted [PDF, 334 KB] (opens in new tab) |
18 Sep 2017 | IRISpec CA/CB/CC, Iris Diagnostics (HSA 600:41/01-052/17/11_67) | HSA 6004101-052-17-11_67 FSN_Redacted [PDF, 265 KB] (opens in new tab) |
15 Sep 2017 | Permobil Powered Wheelchair, Permobil AB (HSA 600:41/01-150/17/01_51) | HSA 6004101-150-17-01_51 FSN_Redacted [PDF, 618 KB] (opens in new tab) |
15 Sep 2017 | ETEST POLYMYXIN B PO 1024 WW B100/VANCOMYCIN VA 256 WW F100/BENZYLPENICIL PG 256 WW F100/VANCOMYCIN VA 256 WW S30 (9302553)/ETEST AMPHOTERICIN-B AP 32 WW B100/OXIDASE 50 AMP bioMérieux SA (HSA 600:41/01-146/17/10_65) | HSA 6004101-146-17-10_65 FSN [PDF, 399 KB] (opens in new tab) |
15 Sep 2017 | Covidien Endo GIA™ Ultra Universal Stapler and Endo GIA™ Reload with Tri-Staple™ Technology, Covidien llc (HSA 600:41/01-046/17/07_50) | HSA 6004101-046-17-07_50 FSN_Redacted [PDF, 3632 KB] (opens in new tab) |
14 Sep 2017 | da Vinci Xi Surgical System, Intuitive Surgical, Inc (HSA 600:41/01-070/17/16_54) | HSA 6004101-070-17-16_54 FSN [PDF, 283 KB] (opens in new tab) |
14 Sep 2017 | APTUS HELI-FX THORACIC ENDOANCHOR SYSTEM HELI-FX GUIDE 42MM, Medtronic Inc (HSA 600:41/01-009/17/18_18) | HSA 6004101-009-17-18_18 FSN_Redacted [PDF, 140 KB] (opens in new tab) |
13 Sep 2017 | Revolve Advanced Adipose System (Revolve System) , Lifecell Corporation (HSA 600:41/01-315/17/01_40) | HSA 6004101-315-17-01_40 FSN [PDF, 372 KB] (opens in new tab) |
13 Sep 2017 | Fluorocell PLT, Sysmex Corporation (HSA 600:41/01-032/17/04_61) | HSA 6004101-032-17-04_61 FSN_Redacted [PDF, 627 KB] (opens in new tab) |
12 Sep 2017 | Medtronic MiniMed Infusion Sets, Medtronic MiniMed (HSA 600:41/01-009/17/17_19) | HSA 6004101-009-17-17_19 FSN_Redacted [PDF, 514 KB] (opens in new tab) |
08 Sep 2017 | Oxoid CAZIO CEFTAZIDIME, CT1629B, OXOID LIMITED (HSA 600:41/01-178/17/05_60) | HSA 6004101-178-17-05_60 FSN_Redacted [PDF, 123 KB] (opens in new tab) |
08 Sep 2017 | Smiths Medical CADD® Medication Cassette Reservoir, Smiths Medical MD, Inc. (HSA 600:41/01-017/17/03_60) | HSA 6004101-017-17-03_60 FSN [PDF, 931 KB] (opens in new tab) |
08 Sep 2017 | Slit Lamp, Carl Zeiss Meditec Ag (HSA 600:41/01-136/17/03_25) | HSA 6004101-136-17-03_25 FSN [PDF, 33 KB] (opens in new tab) |
07 Sep 2017 | Carl Zeiss VisuMax Laser Keratome, Carl Zeiss Meditec AG (HSA 600:41/01-136/17/04_50) | HSA 6004101-136-17-04_50 FSN [PDF, 28 KB] (opens in new tab) |
07 Sep 2017 | Intrabeam System, Carl Zeiss Meditec Ag (HSA 600:41/01-136/17/05_46) | HSA 6004101-136-17-05_46 FSN [PDF, 71 KB] (opens in new tab) |
06 Sep 2017 | cobas u cuvette, Roche Diagnostics GmbH (HSA 600:41/01-016/17/17_61) | HSA 6004101-016-17-17_61 FSN [PDF, 451 KB] (opens in new tab) |
06 Sep 2017 | Siemens Artis Zee & Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/26_64) | HSA 6004101-022-17-26_64 FSN_Redacted [PDF, 205 KB] (opens in new tab) |
06 Sep 2017 | Alinity hq Analyzer, Abbott GmbH (HSA 600:41/01-005/17/14_59) | HSA 6004101-005-17-14_59 FSN [PDF, 97 KB] (opens in new tab) |
05 Sep 2017 | Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/06_58) | HSA 6004101-027-17-06_58 FSN_Redacted [PDF, 2342 KB] (opens in new tab) |
04 Sep 2017 | Model 53912 External Pulse Generator (EPG) Extension Cable, Reusable Model 53912A EPG Extension Cable, packaged with Model 5391 EPG, Model 53912D EPG Extension Cable, Disposable, Medtronic Inc (HSA 600:41/01-009/17/16_18) | HSA 6004101-009-17-16_18 FSN_Redacted [PDF, 74 KB] (opens in new tab) |
04 Sep 2017 | Philips Digital Diagnost Radiography System, DMC GmbH (HSA 600:41/01-026/17/14_46) | HSA 6004101-026-17-14_46 FSN_Redacted [PDF, 103 KB] (opens in new tab) |
04 Sep 2017 | Alaris LVP (Large Volume Pump) model 8100, CareFusion 303 Inc (HSA 600:41/01-003/17/18_63) | HSA 6004101-003-17-18_63 FSN_Redacted [PDF, 1702 KB] (opens in new tab) |
04 Sep 2017 | BD Insulin Syringe, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/17_25) | HSA 6004101-003-17-17_25 FSN_Redacted [PDF, 284 KB] (opens in new tab) |
04 Sep 2017 | ID-DiaCell l-ll-III, DiaMed GmbH (HSA 600:41/01-027/17/05_59) | HSA 6004101-027-17-05_59 FSN_Redacted [PDF, 2932 KB] (opens in new tab) |
04 Sep 2017 | IMPAC Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/07_56) | HSA 6004101-101-17-07_56 FSN_Redacted [PDF, 233 KB] (opens in new tab) |
09 Aug 2017 | Trident, Accolade, Accolade II and Restoration Modular implants, Howmedica Ostenics Corp (HSA 600:41/01-014/17/05_56) | HSA 6004101-014-17-05_56 FSN (updated)_Redacted [PDF, 175 KB] (opens in new tab) |