My HPRA: Register

Summary of Field Safety Notice – April 2016

Notice type: 3rd Party Publications

Date: 03/05/2016

  

Further Information:
Applied Medical
CA090 Direct Drive Clip Appliers
Advice regarding a device removal: HPRA Ref: V27426

ArjoHuntleigh AB
Akron Echo 2 
Advice regarding a device modification: HPRA Ref: V27251

Bio-Rad
ID-Papain
Advice regarding a device removal: HPRA Ref: V27532

Cook Medical
Beacon Tip Angiographic Catheters and Procedure packs
Advice regarding a device removal: HPRA Ref: V27566

Datex-Ohmeda, Inc. (GE Healthcare)
Aisys CS2 and upgraded Aisys anesthesia devices with software version 10.X
Advice regarding a software upgrade: HPRA Ref: V27195

DePuy Synthes
Pangea Degenerative & Pedicle Awls
Advice regarding changes/updates made to instructions for use: HPRA Ref: V23624

Hologic
Hologic ThinPrep® 5000 Processor with Autoloader
Advice regarding a software upgrade: HPRA Ref: V27447

James Leckey Design Limited
Mygo Stander
Advice regarding a device modification: HPRA Ref: V27368

Leica Biosystems
Novocastra Lyophilised Mouse Monoclonal Antibody Renal Cell Carcinoma Marker
Advice regarding a device removal: HPRA Ref: V27518

Optimed Medizinische Instrumente GmbH
Zelos PTA-Balloon Catheter
Advice regarding a device removal: HPRA Ref: V27563

Ortho Clinical Diagnostics
ORTHO VISION® Analyzers and ORTHO VISION® Max Analyzers
Advice regarding the use of the device: HPRA Ref: V27003

Ortho Clinical Diagnostics
VITROS® 3600 Immunodiagnostics System and VITROS® 5600 Integrated System
Advice regarding a software upgrade: HPRA Ref: V27467

Phadia AB
EliA CCP Positive Control
Advice regarding the use of the device: HPRA Ref: V27598

Philips Ultrasound Inc
Philips EPIQ Ultrasound System
Advice regarding a device modification: HPRA Ref: V27373

Richard Wolf GmbH
Pump Tube, 8170,861
Advice regarding a device removal: HPRA Ref: V27446

Roche Diagnostics
cobas® EGFR Mutation Test v2
Advice regarding changes/updates made to instructions for use: HPRA Ref: V27460

Roche Diagnostics
AssayTip/AssayCup
Advice regarding a device removal: HPRA Ref: V27619

SenoRX, Inc. (BARD Limited)
Bard Encor® Probes
Advice regarding the use of the device: HPRA Ref: V27601

Sero
Seronorm
Advice regarding the use of the device: HPRA Ref: V27605

Sero 
Pantonorm
Advice regarding the use of the device: HPRA Ref: V27606

Sero 
Seronorm Paediatric
Advice regarding the use of the device: HPRA Ref: V27607

Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry systems
Advice regarding changes/updates made to instructions for use: HPRA Ref: V27367

Siemens Healthcare Diagnostics, Inc.
Dimension clinical chemistry systems; Dimension Vista System
Advice regarding changes/updates made to instructions for use: HPRA Ref: V27367

Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur CP
Advice regarding the use of the device: HPRA Ref: V27396

Siemens Medical Solutions USA
E.Cam and Symbia Systems with Foresight Detectors
Advice regarding a software upgrade: HPRA Ref: V27359

Smiths Medical International Ltd.
Medex ™ Cardiothoracic Custom sets
Advice regarding a device removal: HPRA Ref: V27538

Tem Innovations
ROTEM sigma complete+hep 555502; ROTEM sigma complete 555501
Advice regarding a device removal: HPRA Ref: V27611

Zimmer Biomet
Biolox Delta Ceramic Head 32mm Standard Neck, Type 1 Taper / Biolox Delta Ceramic Head 36mm Standard Neck Type, 12/14 Taper
Advice regarding a device removal: HPRA Ref: V27424
 

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