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Summary of Field Safety Notice – January 2018
Notice type:
3rd Party Publications
Date:
01/02/2018
Further Information:
Acromed AG
Syramed µSP6000 and Volumed µVP7000
Advice regarding the use of the device. HPRA Ref: V34284
Agilent Technologies Denmark ApS / Dako
Artisan Classic / Artisan Link / Artisan Link Pro
Advice regarding the use of the device. HPRA Ref: V34451
Animas
Animas® Vibe® Insulin Pump Letter 1
Animas® Vibe® Insulin Pump Letter 2
Animas® Vibe® Insulin Pump Letter 3
Advice regarding a device removal. HPRA Ref: SD24520
arKray
Recall for SPOTCHEM II Glucose, SPOTCHEM II PANEL-1, SPOTCHEM II PANEL-V and SPOTCHEM II PANEL-V2
Advice regarding a device removal. HPRA Ref: V34259
Beckman Coulter
DxH 500
Advice regarding a software upgrade. HPRA Ref: V34161
Beckman Coulter
COULTER® EPICS® XL™ Flow Cytometer, COULTER EPICS XL-MCL™ Flow Cytometer and FC 500™ Series Flow Cytometers - FSN 1
COULTER® EPICS® XL™ Flow Cytometer, COULTER EPICS XL-MCL™ Flow Cytometer and FC 500™ Series Flow Cytometers - FSN 2
Advice regarding the use of the device. HPRA Ref: V34333
Becton, Dickinson & Company
BD Phoenix GramNegative Panels containing Colistin
Advice regarding the use of the device. HPRA Ref: V34359
BioMerieux
VIDAS And miniVIDAS Clinical
Advice regarding the use of the device. HPRA Ref: V34321
Coloplast A/S
Biatain Ag dressing and Biatain Ibu dressing
Advice regarding a device removal. HPRA Ref: V34471
DePuy Spine
CONFIDENCE KIT SPINAL CEMENT SYSTEM
Advice regarding a device removal. HPRA Ref: V34155
Hologic
Panther® and Panther® Fusion Systems Touch Screen Monitor
Advice regarding a device modification. HPRA Ref: V34385
Intersurgical Ltd.
BVM (Bag-Valve-Mask) Manual Resuscitation Systems
Advice regarding a device removal. HPRA Ref: V34223
MAKO Surgical Corp
Mako RIO System Ethernet to Fiber Optic Converter
Advice regarding a device modification. HPRA Ref: V34442
MAKO Surgical Corp.
Restoris MCK Onlay Insert Extractor
Advice regarding a device removal. HPRA Ref: V34489
Medtronic
Activa® PC, Activa® SC, Activa® RC and Activa® PC+S Devices
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27816
Medtronic
Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan
Advice regarding a software upgrade. HPRA Ref: V30182
Philips
BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16
Advice regarding the use of the device. HPRA Ref: V34308
Philips
Philips IntelliVue Information Center (PIIC) iX - FSN 1
Philips IntelliVue Information Center (PIIC) iX - FSN 2
Advice regarding a software upgrade. HPRA Ref: V34335
Philips
Allura Xper systems
Advice regarding a device modification. HPRA Ref: V34339
Siemens Healthcare Diagnostics Inc.
IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34156
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur® / ADVIA Centaur®XP / ADVIA Centaur®XPT / ADVIA Centaur®CP - Biotin Interference in the Cyclosporine, DHEA-SO4, Folate and HBc IgM Assays
Advice regarding the use of the device. HPRA Ref: V34303
Siemens Healthcare GmbH
syngo Workflow MLR
Advice regarding a software upgrade. HPRA Ref: V34273
Smiths Medical
CADD® Medication Cassette Reservoirs
Advice regarding a device removal. HPRA Ref: V33553
Smiths Medical
Medfusion® Syringe Pump, Model Series 3500 and 4000
Advice regarding the use of the device. HPRA Ref: V34348
Stanmore Implants
Custom Made Implant Systems with Minimally Invasive Grower (MIG) component
Advice regarding the use of the device. HPRA Ref: V34205
Starkey Hearing Technologies
Ear Mould Starkey
Advice regarding the use of the device. HPRA Ref: V34005
Stryker
Slap Hammer, Non Threaded Impactor, Head Impactor
Advice regarding the use of the device. HPRA Ref: V33883
United Orthopedic Corporation
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick /U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick
Advice regarding a device removal. HPRA Ref: V33913
Ventana Medical Systems Inc. / Roche Tissue Diagnostics
Hematoxylin II and Horseradish Peroxidase reagents
Advice regarding the use of the device. HPRA Ref: V34208
W&H Dentalwerk Bürmoos GmbH
Foot Control S-N1 / S-N2
Advice regarding a device modification. HPRA Ref: V34282
Xograph Technologies Ltd
AMT15750 Tracheal Tube Bougie
Advice regarding a device removal. HPRA Ref: V33909
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Date Printed: 01/04/2023