My HPRA: Register

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

« Back