Field Safety Notices
Field Safety Notice - Jul 2017
31 July 2017
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 Jul 2017 | ADVIA Centaur T3, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/23_60) | HSA 6004101-022-17-23_60 FSN [PDF, 221 KB] (opens in new tab) |
31 Jul 2017 | Zimmer A.T.S. (Autotmatic Torniquet System) 2200TS and 4000TS, Zimmer Surgical, Inc (HSA 600:41/01-008/17/09_46) | HSA 6004101-008-17-09_46 FSN_Redacted [PDF, 248 KB] (opens in new tab) |
31 Jul 2017 | PneumoCryoprobe; Flexible, Erbe Elektromedizin GmbH (HSA 600:41/01-312/17/01_48) | HSA 6004101-312-17-01_48 FSN_Redacted [PDF, 142 KB] (opens in new tab) |
31 Jul 2017 | Advance XP Male Sling System, Boston Scientific (HSA 600:41/01-142/17/01_54) | HSA 6004101-142-17-01_54 FSN_Redacted [PDF, 320 KB] (opens in new tab) |
28 Jul 2017 | Siemens Dimension® Alanine Aminotranferase (ALTI) Flex® reagent cartridge, Siemens ADVIA Chemistry 1800, 2400, XPT Ammonia (AMM), Siemens ADVIA Chemistry 1800, 2400, XPT Alanine Aminotransferase (ALT), Siemens ADVIA Chemistry 1800, 2400, XPT Salicylate (SAL), Siemens Dimension® Aspartate Aminotransferase (AST) Flex® reagent cartridge, Siemens Dimension® Glucose Flex® reagent cartridge (GLUC), Siemens Syva® Emit® 2000 Tacrolimus Sample Pretreatment Reagents/Syva® Emit® 2000 Tacrolimus Calibrators/Syva® Emit® 2000 Tacrolimus Assay, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/17/22_59) | HSA 6004101-022-17-22_59_FSN [PDF, 68 KB] (opens in new tab) |
28 Jul 2017 | AIRO Mobile CT Scanner, BrainLab AG (HSA 600:41/01-047/17/02_46) | HSA 6004101-047-17-02_46 FSN_Redacted [PDF, 375 KB] (opens in new tab) |
27 Jul 2017 | BD Multitest CD3/CD8/CD45/CD4, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/15_58) | HSA 6004101-003-17-15_58 FSN_Redacted [PDF, 49 KB] (opens in new tab) |
26 Jul 2017 | VersaSafe Plastic Cannula – 11 Gauge, CareFusion 303 Inc (HSA 600:41/01-003/17/14_25) | HSA 6004101-003-17-14_25 FSN_Redacted [PDF, 2744 KB] (opens in new tab) |
25 Jul 2017 | Percuvance® Percutaneous Surgical System, Teleflex Medical (HSA 600:41/01-139/17/02_43) | HSA 6004101-139-17-02_43 FSN_Redacted [PDF, 173 KB] (opens in new tab) |
20 Jul 2017 | Vertaplex, Spineplex IVS cement and cement containing kits, Stryker Instruments (HSA 600:41/01-014/17/04_51) | HSA 6004101-014-17-04_51 FSN_Redacted [PDF, 101 KB] (opens in new tab) |
20 Jul 2017 | Proteus 235 - Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/17/12_51) | HSA 6004101-070-17-12_51 FSN_Redacted [PDF, 302 KB] (opens in new tab) |
20 Jul 2017 | HomeChoice Automated PD Cycler, 230V; HomeChoice PRO Automated PD Cycler, 230V, Baxter Healthcare SA (HSA 600:41/01‐001/17/03_44) | HSA 6004101-001-17-03_44 FSN_Patient Letter_Redacted [PDF, 2195 KB] (opens in new tab) HSA 6004101-001-17-03_44 FSN_Center Letter_Redacted [PDF, 1143 KB] (opens in new tab) |
19 Jul 2017 | Leica M525 F40 Surgical Microscopes, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/17/02_40) | HSA 60041-01-126-17-02_40 FSN_Redacted [PDF, 346 KB] (opens in new tab) |
19 Jul 2017 | Alere HIV Combo, Alere Medical Co. Ltd (HSA 600:41/01-111/17/02_38) | HSA 6004101-111-17-02_38 FSN [PDF, 73 KB] (opens in new tab) |
19 Jul 2017 | SMARTABLATE™RF GENERATOR SYSTEM, Biosense Webster Inc (HSA 600:41/01-002/17/08_36) | HSA 6004101-002-17-08_36 FSN_Redacted [PDF, 105 KB] (opens in new tab) |
18 Jul 2017 | CS100IABP, CS300IABP, Datascope Corp (HSA 600:41/01-081/17/02_35) | HSA 6004101-081-17-02_35 FSN_Redacted [PDF, 106 KB] (opens in new tab) |
18 Jul 2017 | cobas c 501 module & cobas c 502 module, Roche Diagnostics GmbH (HSA 600:41/01-016/17/14_34) | HSA 6004101-016-17-14_34 FSN [PDF, 210 KB] (opens in new tab) |
17 Jul 2017 | Mueller Hinton E Agar (MHE), bioMérieux SA (HSA 600:41/01-146/17/09_31) | HSA 6004101-146-17-09_31 FSN [PDF, 315 KB] (opens in new tab) |
17 Jul 2017 | SPINOUS PROCESS CLAMPS, Medtronic Navigation, Inc (HSA 600:41/01-009/17/15_19) | HSA 6004101-009-17-15_19 FSN_Redacted [PDF, 1336 KB] (opens in new tab) |
14 Jul 2017 | VITROS Chemistry Products Performance Verifier II, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/09_31) | HSA 6004101-303-17-09_31 FSN_Redacted [PDF, 210 KB] (opens in new tab) |
14 Jul 2017 | VITEK® 2 Compact, bioMérieux, Inc. (HSA 600:41/01-146/17/08_60) | HSA 6004101-146-17-08_60 FSN [PDF, 296 KB] (opens in new tab) |
14 Jul 2017 | Absorb and Absorb GT1 Bioresorbable Vascular Scaffold (BVS) Systems, Abbott Vascular (HSA 600:41/01-005/17/10_35) | HSA 6004101-005-17-10_35 FSN [PDF, 59 KB] (opens in new tab) |
14 Jul 2017 | Medtronic MyCareLink™ Remote Monitors, Medtronic Inc (HSA 600:41/01-009/17/14_25) | HSA 6004101-009-17-14_25 FSN_Redacted [PDF, 289 KB] (opens in new tab) |
13 Jul 2017 | ARJOHUNTLEIGH FLOWTRON ACS900, ArjoHuntleigh AB (HSA 600:41/01-065/17/01_64) | HSA 6004101-065-17-01_64 FSN_Redacted [PDF, 134 KB] (opens in new tab) |
13 Jul 2017 | Euphora Rapid Exchange Balloon Dilatation Catheters, Medtronic Inc (HSA 600:41/01-009/17/13_46) | HSA 6004101-009-17-13_46 FSN_Redacted [PDF, 107 KB] (opens in new tab) |
12 Jul 2017 | CARESCAPE Patient Data Module (PDM) on CARESCAPE B850/650/450, GE Medical Systems Information Technologies Inc. (HSA 600:41/01-010/17/04_36) | HSA 6004101-010-17-04_36 FSN_Redacted [PDF, 72 KB] (opens in new tab) |
11 Jul 2017 | Gambro AK 98 Dialysis Machine, Gambro Lundia AB (HSA 600:41/01-001/17/02_63) | HSA 6004101-001-17-02_63 FSN_Redacted [PDF, 2458 KB] (opens in new tab) |
11 Jul 2017 | SYNCHRON® System(s) Salicylate (SALY), Beckman Coulter Inc. (HSA 600:41/01-052/17/09_67) | HSA 6004101-052-17-09_67 FSN_Redacted [PDF, 102 KB] (opens in new tab) |
10 Jul 2017 | Automated Digital Cell Morphology Analyzer DI-60, CellaVision AB (HSA 600:41/01-032/17/01_65) | HSA 6004101-032-17-01_65 FSN_Redacted [PDF, 1219 KB] (opens in new tab) |
07 Jul 2017 | OPTI CCA B-Lac Cassette, OPTI Medical Systems, Inc. (HSA 600:41/01-033/17/04_60) | HSA 6004101-033-17-04_60 FSN [PDF, 50 KB] (opens in new tab) |
07 Jul 2017 | Set 9734378 Supplemental Ins Axiem Ent, Medtronic Navigation, Inc (HSA 600:41/01-009/17/12_50) | HSA 6004101-009-17-12_50 FSN_Redacted [PDF, 2074 KB] (opens in new tab) |
06 Jul 2017 | LipiFlow System Activator (Disposable), TearScience Inc (HSA 600:41/01-110/17/02_40) | HSA 60041-01-110-17-02_40 FSN [PDF, 417 KB] (opens in new tab) |
06 Jul 2017 | Microgenics Multigent Quinidine Assay, Microgenics Corporation (HSA 600:41/01-005/17/09_58) | HSA 60041-01-005-17-09_58 FSN_Redacted [PDF, 195 KB] (opens in new tab) |
06 Jul 2017 | Boston Scientific ILab Ultrasound Imaging System (FFR Link), Boston Scientific Corporation (HSA 600:41/01-007/17/08_48) | HSA 6004101-007-17-08_48 FSN_Redacted [PDF, 237 KB] (opens in new tab) |
05 Jul 2017 | Galaxy Unyco Diaphyseal Tibia Sterile Kit, OrthoFix Srl (HSA 600:41/01-115/17/01_44) | HSA 6004101-115-17-01_44 FSN_Redacted [PDF, 156 KB] (opens in new tab) |
05 Jul 2017 | Roche Diagnostics cobas e 602, cobas e 601 and E170 modules, Roche Diagnostics GmbH (HSA 600:41/01-016/17/12_58) | HSA 6004101-016-17-12_58 FSN [PDF, 2196 KB] (opens in new tab) |
03 Jul 2017 | Novopen Echo, Novo Nordisk A/S (HSA 600:41/01-311/17/01_49) | HSA 6004101-311-17-01_49_HCPs FSN_Redacted [PDF, 145 KB] (opens in new tab) HSA 6004101-311-17-01_49_Pharmacies FSN_Redacted [PDF, 134 KB] (opens in new tab) HSA 6004101-311-17-01_49_patients FSN_Redacted [PDF, 78 KB] (opens in new tab) |
15 Feb 2017 | Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/02_60) | HSA 6004101-027-17-02_60 FSN Part 3_Redacted [PDF, 5269 KB] (opens in new tab) |