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Summary of Field Safety Notices - August 2015

Notice type: 3rd Party Publications

Date: 01/09/2015

Further Information:
Aesculap AG
Metha Titanium Cone Adapter (Neck)
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V25372

Atom Scientific
Neutral Red 0.5% Aqueous, Gram Stain Kit (Neutral Red Counterstain)
Advice regarding a device removal. HPRA Ref: V24916

Baxter Healthcare Corporation
Actifuse ABX products
Advice regarding a device removal. HPRA Ref: V25381

BD
BD Vacutainer, Eclipse, Signal Blood Collection Needle with Integrated Holder
Advice regarding the use of the device. HPRA Ref: V25322

Beckman Coulter
Access Thyroglobulin Reagent Kit
Advice regarding a device removal. HPRA Ref: V25097

BioMérieux
chromID S.aureus reagents
Advice regarding a device removal. HPRA Ref: V25370

Biomet 3i
RASH3N and RASQ3N Driver Tip
Advice regarding a device removal. HPRA Ref: V25307

Boston Scientific
WATCHMAN® Left Atrial Appendage Closure Device with Delivery System and WATCHMAN® Access System Access Sheath with Dilator.
Advice regarding the use of the device. HPRA Ref: V25415

Brainlab AG
Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems
Advice regarding the use of the device. HPRA Ref: V25325

Brainlab AG
ExacTrac v 6.0.0 - 6.0.5
Advice regarding a software upgrade. HPRA Ref: V25135

Caesarea Medical Electronics
Bodyguard 575 PCA Infusion Pump
Advice regarding a software upgrade. HPRA Ref: V25155

DePuy Synthes
Socket, hexagonal Ø 4.0/11.0mm, cannulated
Advice regarding a device removal. HPRA Ref: V25170

Edwards Lifesciences LLC
Edwards Commander Delivery System, models 9610TF23, 9610TF26, 9610TF29
Advice regarding a device removal. HPRA Ref: V23403

Eizo Corporation
RadiForce RX440, RX650, RX850 and GX540 with Display Port
Advice regarding a software upgrade. HPRA Ref: V25173

Fresenius Medical Care
FX CorDiax High-Flux dialysers, FX CorDiax Haemodiafilters
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23625

GE Healthcare IT
Centricity PACS-IW with Universal Viewer
Advice regarding a software upgrade. HPRA Ref: V25355

Halyard Health
KIMVENT* Closed Suction System for Adults (12F T-Piece, 14F DSE), Neonates/Pediatrics (8F Y-Adapter)
Advice regarding the use of the device. HPRA Ref: V25441

IMPAC Medical Sysytems/Elekta
XiO Radiotherapy Treatment Planning System with Elekta
Advice regarding a software upgrade. HPRA Ref: V25443

Medtronic Limited
Medtronic Deep Brain Stimulation (DBS) Therapy - Activa PC, Activa RC, Activa PC+S, Kinetra, and Soletra.
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24953

Northern Digital Inc (NDI)
NDI Disposable Reflective Marker Spheres
Advice regarding a device removal. HPRA Ref: V24673

Philips Goldway (Shenzhen) Industrial Inc
Goldway G60 Monitor
Advice regarding a device modification. HPRA Ref: V25244

Philips Medical Systems
Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128
Advice regarding a software upgrade. HPRA Ref: V25420

Roche Diagnostics
S3 Fluid Pack A and S2 Fluid Pack
Advice regarding a device removal. HPRA Ref: V24364

Siemens AG
Acuson SC2000
Advice regarding a software upgrade. HPRA Ref: V25423

Siemens Healthcare Diagnostics
N Latex ß2-Microglobulin & DV Flex Reagent B2MIC
Advice regarding a device removal. HPRA Ref: V24864

Siemens Healthcare Diagnostics
Ascorbic Acid/Ascorbic Acid Diluent
Advice regarding a device removal. HPRA Ref: V25036

Siemens Healthcare Diagnostics
ADVIA Centaur Systems HBsAg II
Advice regarding the use of the device. HPRA Ref: V25430

Siemens Healthcare Diagnostics, Inc.
RAPIDPoint 500 System Measurement Cartridge Lactate
Advice regarding the use of the device. HPRA Ref: V25431

Teleflex Medical
Flexi-Slip Endotracheal Tube Stylet
Advice regarding a device removal. HPRA Ref: V25378

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