My HPRA: Register

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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