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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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Date Printed: 27/04/2024