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Summary of Field Safety Notices - December 2016
Notice type:
3rd Party Publications
Date:
04/01/2017
Further Information:
Agfa Healthcare
NX 3.0.8950 image processing software
Advice regarding a software upgrade. HPRA Ref: V30298
Ascensia
CONTOUR® DIABETES APP AND CONTOUR CLOUD SYNCHRONIZATION
Advice regarding a software upgrade. HPRA Ref: V30108
Baxter Healthcare Corporation
Artiset HD SN HC
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30162
Beckman Coulter
UniCel DxH 800/600 Cellular Analysis Systems
Advice regarding the use of the device. HPRA Ref: V30297
Biomerieux
ETEST COLISTIN
Advice regarding the use of the device. HPRA Ref: V28694
BioSciTec GmbH
BLOTrix 3.4 software
Advice regarding a software upgrade. HPRA Ref: V30114
Boston Scientific
Imager™ II Angiographic Catheter
Advice regarding the use of the device. HPRA Ref: V30292
BrainLab
iPlan RT and iPlan RT Dose (all versions), BrainSCAN (discontinued)
Advice regarding a software upgrade. HPRA Ref: V30226
CareFusion
Alaris VP Plus with Guardrails
Advice regarding the use of the device. HPRA Ref: V30190
CSC
i.Laboratory 5.8.1002
Advice regarding the use of the device. HPRA Ref: V30170
DePuy Synthes
PFNA Blade Impactor
Advice regarding a device removal. HPRA Ref: V30236
Elekta
Oncentra® External Beam Oncentra® Brachy
Advice regarding a software upgrade. HPRa Ref: V30335
Endologix International Holdings B.V.
AFX EndoVascular AAA System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30316
GE Healthcare
Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems
Advice regarding a device modification. HPRA Ref: V30115
Hamamatsu Photonics Deutschland GmbH
Nanozoomer
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30154
HOYA Corporation
Pentax Medical Endoscopes, all models
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30352
Immucor Gamma
Kleihauer Kit, 0098100
Advice regarding the use of the device. HPRA Ref: V29737
Lifepoint (Medeks Medikal)
Medeks MedikalAdult and Paediatric Electrode Pads for Lifepoint AEDs
Advice regarding a device removal. HPRA Ref: V30286
Maquet/Getinge
Heater-Cooler Unit HCU 40
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30230
Medtronic
SynchroMed® II Programmable Pump
Advice regarding a software upgrade. HPRA Ref: V30285
Medtronic
Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™
Advice regarding a software upgrade. HPRA Ref: V30182
Medtronic
Nellcor™ SpO2 Forehead Sensor
Advice regarding a device removal. HPRA Ref: V30260
Merge Healthcare
eFilm Workstation/eFilm Lite User
Advice regarding a software upgrade. HPRA Ref: V30172
Ortho Clinical Diagnostics
ORTHO VISION® and VISION® Max Analyzers for BioVue
Advice regarding the use of the device. HPRA Ref: V30124
Ortho Clinical Diagnostics
ORTHO VISION® and VISION Max Analyzers with Software Version 3.6.0 and Below
Advice regarding the use of the device. HPRA Ref: V30039
Roche Diagnostics GmbH
PreciControl Varia
Advice regarding the use of the device. HPRA Ref: V30159
Roche Diagnostics GmbH
Multiplate® Analyzer
Advice regarding a device modification. HPRA Ref: V30364
Siemens Healthcare
Artis zee, Artis Q, and Artis Q.zen systems with software version VD11B
Advice regarding a software upgrade. HPRA Ref: V30161
Stanmore Implants
METS Modular Proximal Humerus System
Advice regarding a device removal. HPRA Ref: V30319
Straumann
Fluted Surgical Drill
Advice regarding a device removal. HPRA Ref: V30119
Synergy Health
Vernaid Cotton Stretch Drape-FSN1
Vernaid Cotton Stretch Drape-FSN2
Advice regarding a device removal. HPRA Ref: V30264
Trinity Biotech
Glucose-6-Phospate Dehydrogenase (G-6-PDH)
Advice regarding a device removal. HPRA Ref: V29906
Vygon
AutoFlush
Advice regarding a device removal. HPRA Ref: V30300
Zimmer Biomet
Gender Solutions Milling Handpiece
Advice regarding a device removal. HPRA Ref: V30149
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Date Printed: 27/07/2024