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Summary of Field Safety Notice – July 2016
Notice type:
3rd Party Publications
Date:
03/08/2016
Further Information:
Abbott laboratories
CELL-DYN Emerald Cleaner
Advice regarding the use of the device: HPRA Ref: V27331
Baxter Healthcare Corporation
VASCU-GUARD Peripheral Vascular Patch
Advice regarding a device removal: HPRA Ref: V28322
Baxter Healthcare SA
Cyto Luer Set
Advice regarding the use of the device: HPRA Ref: V26060
Biomerieux
NucliSENS® easyMAG® Magnetic Silica
Advice regarding the use of the device: HPRA Ref: V28377
Covidien
Covidien Valleylab™ Laparoscopic Electrodes
Advice regarding a device removal: HPRA Ref: V28348
DePuy Synthes
Adapter for Colibri, for Electric Pen Drive / Adaptor, small, for Colibri (II) and Small Battery Drive (II)
Advice regarding a device removal: HPRA Ref: V28395
Etac AS Etac Supply Gjøvik
Molift Air 205 & 3000
Advice regarding a device modification: HPRA Ref: V28262
Fannin
W11054 Columbia Blood Agar 90m Double Wrap, W11305 Columbia Blood Agar + Neomycin, W11340 Streptococcus Medium, W11050 Columbia Blood Agar
Advice regarding a device removal: HPRA Ref: V28346
Hill-Rom Incorporated
PROGRESSA BED SYSTEM
Advice regarding a software upgrade: HPRA Ref: V28293
Intuitive Surgical Inc.
da Vinci® Xi™ EndoWrist Stapler
Advice regarding a device removal: HPRA Ref: V28561
Leica Biosystems Nussloch GmbH
ASP63025 Tissue Processor
Advice regarding the use of the device: HPRA Ref: V25091
Lohmann & Rauscher GmbH
Metalline Products
Advice regarding a device removal: HPRA Ref: V28132
MacoPharma
Missing cuts in lateral weld (CV1014)
Advice regarding the use of the device: HPRA Ref: V27997
Maquet GmbH & Co. KG
Headrest Fixture 1002.65A0
Advice regarding a device modification: HPRA Ref: V28478
McKesson Medical Imaging Company
McKesson Radiology (MR)
Advice regarding a software upgrade: HPRA Ref: V28494
Medtronic B.V.
O-arm® 1000 Surgical Imaging System, O-arm® O2 Surgical Imaging System
Advice regarding the use of the device: HPRA Ref: V28472
Natus Medical Incorporated
neoBLUE LED Phototherapy System
Advice regarding the use of the device: HPRA Ref: V28362
Nipro Diagnostics
TRUEresult Blood Glucose Test Strips
Advice regarding a device removal: HPRA Ref: V27790
Novus Scientific
Tigr® Matrix Surgical Mesh
Advice regarding changes/updates made to instructions for use: HPRA Ref: V28457
Philips Medical Systems Nederland B.V.
MultiDiagnost Eleva, UroDiagnost, MultiDiagnost Eleva with Flat Detector
Advice regarding a device modification: HPRA Ref: V28483
Philips Medical Systems Nederland B.V.
Allura Xper and UNIQ
Advice regarding a device modification: HPRA Ref: V28339
Randox Laboratories Limited
Lipase, L13837, L17979, L18050, L18361 – RX Instruments
Advice regarding the use of the device: HPRA Ref: V28438
Roche
cobas b 123 < 3 > POC system, cobas b 123 < 4 > POC system
Advice regarding the use of the device: HPRA Ref: V28396
Roche Diagnostics
ONLINE TDM Gentamicin 100 Tests c 311, c 501/502, ONLINE TDM Gentamicin 100 Tests c 701/702, ONLINE TDM Gentamicin Mod P
Advice regarding the use of the device: HPRA Ref: V27920
SCIEX
MultiQuant MD software - Version 3.0, 3.0.1 and 3.0.2. Component of the API 3200MDTM LC/MS/MS system, 3200MD QTRAP® LC/MS/MS system, Triple QuadTM 4500MD LC/MS/MS system, and QTRAP® LC/MS/MS system
Advice regarding the use of the device: HPRA Ref: V28283
Siemens
Xprecia Stride™ Coagulation Analyzer
Advice regarding the use of the device: HPRA Ref: V28622
Siemens AG; Healthcare Sector
Artis Zee Ceiling System
Advice regarding a device modification: HPRA Ref: V20517
Siemens Medical Solutions Diagnostics Europe Limited
AXIOM Artis, Artis Zee and Artis Q/Q.zen systems
Advice regarding a device modification: HPRA Ref: V28482
Smith & Nephew
Sterile RENASYS™ Transparent Film
Advice regarding a device removal: HPRA Ref: V28554
Stryker Orthopaedics
Trident Constrained Liner Impactor Tips
Advice regarding a device removal: HPRA Ref: V28269
Stryker Orthopaedics
Triathlon Modular Handle
Advice regarding a device removal: HPRA Ref: V28383
TEC COM GmbH
TECOTHERM NEO
Advice regarding a software upgrade: HPRA Ref: V28246
ThermoFisher
ThermoScientificTM OxoidTM Columbia Blood Agar Base CM0331
Advice regarding the use of the device: HPRA Ref: V28346
ThermoFisher Scientific
ThermoScientificTM OxoidTM GC Agar, CM0367 (B,R,T,Q)
Advice regarding a device removal: HPRA Ref: V28249
Xiros
Infinity Lock and disposable instrument set
Advice regarding a device removal: HPRA Ref: V28209
Xiros
Infinity Lock and disposable instrument set
Advice regarding a device removal: HPRA Ref: V28209
Zimmer Biomet
Zimmer® Air Dermatome II Handpiece and Width Plate
Advice regarding a device removal: HPRA Ref: V28394
Zimmer Biomet
Zimmer® Air Dermatome II Handpiece and Width Plate
Advice regarding a device removal: HPRA Ref: V28394
Zimmer Biomet
Various Kits Containing ACDA
Advice regarding a device removal: HPRA Ref: V28550
Zimmer Biomet
Various Kits Containing ACDA
Advice regarding a device removal: HPRA Ref: V28550
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Date Printed: 23/04/2024