Summary of Field Safety Notices - March 2019

Notice type: 3rd Party Publications

Date: 02/04/2019

 

Further Information:
Abbott
Alinity i Processing Module, Alinity c Processing Module and Alinity s System. FSN 1
Alinity i Processing Module, Alinity c Processing Module and Alinity s System. FSN 2
Advice regarding a device modification. HPRA Ref: V38923


Abbott
Alinity i Processing Module, Alinity c Processing Module and Alinity s System
Advice regarding a device modification. HPRA Ref: V38924


Abbott
Alinity ciā€series System Control Module (SCM)
Advice regarding the use of the device. HPRA Ref: V39061


ArthroCare Corporation/ Smith & Nephew
SmartStitch PerfectPasser Connector
Advice regarding a device removal. HPRA Ref: V38909


B.Braun
Certofix Quattro V 815, Certofix Quattro V 820, Certofix Quattro V 830, Certofix Quattro V 815-EU/SA, Certofix Quattro V 820-EU/SA, 
Advice regarding a device removal. HPRA Ref: V39040


Beaver-Visitec International Inc.
Beaver® Micro Knife 5.0mm 30, 10/box
Advice regarding a device removal. HPRA Ref: V39136


Biocomposites
Genex Putty 5cc
Advice regarding a device removal. HPRA Ref: V38950


Biofire Diagnostics
BioFire® FilmArray® Blood Culture Identification (BCID) Panel
Advice regarding the use of the device. HPRA Ref: V39424


Brainlab AG
RT Elements Radiation Treatment Planning Software
Advice regarding a software upgrade. HPRA Ref: V39428


BÜHLMANN
BÜHLMANN IBDoc®
Advice regarding a software upgrade. HPRA Ref: V39300


ConMed Corporation
Anchor Tissue Retrieval System™
Advice regarding a device removal. HPRA Ref: V39335


Cordis
Cordis Vista Brite and ADROIT Guiding Catheter
Advice regarding a device removal. HPRA Ref: V38714


Direct Healthcare Group Limited
Mercury Advance V1 Control Unit
Advice regarding a device removal. HPRA Ref: V39419


Draeger Medical Systems, Inc.
Infinity Acute Care System (M540)
Advice regarding a software upgrade. HPRA Ref: V39159


Ethicon Endo-Surgery, LLC
Intraluminal Staplers (ILS)
Advice regarding a device removal. HPRA Ref: V39460


GE Medical Systems Information Technologies, Inc.
CARESCAPE ONE Monitoring Systems
Advice regarding a device modification. HPRA Ref: V38832


Geistlich Pharma AG
Geistlich Bio-Oss Pen
Advice regarding the use of the device. HPRA Ref: V39298


HOGGI GmbH
CLEO Ti Wheelchair 
Advice regarding a device modification. HPRA Ref: V39402


Hugh Steeper Ltd
Select Myoelectric Hand
Advice regarding the use of the device. HPRA Ref: V39413


Leica Biosystems
Leica CM1950, Leica CM1860/UV, Leica CM1520, Leica CM3050 S, Leica CM1850 UV, Leica CM1850, Leica CM1510 S, Leica CM110
Advice regarding changes/updates made to instructions for use. HPRA Ref: V39337


Medtronic
Charging System, RestoreSensor Charging System
Advice regarding the use of the device. HPRA Ref: V29659


Medtronic
StealthStationTM Cranial and SynergyTM Cranial
Advice regarding a software upgrade. HPRA Ref: V37754


Medtronic
Pulmonary Vein Catheter GOLD (PVAC GOLD)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38941


Mortara Instrument Inc
Burdick 4250 Holter recorder
Advice regarding a device removal. HPRA Ref: V38951


Nobel Biocare
Single-patient use drills for NobelReplace (Tapered Drills, Dense Bone Drills, Screw Taps), Guided Start Drills/Counterbores and Guided Counterbores for NobelReplace, Implant Retrieval Instruments and Abutment Screw Retrieval Instruments
Advice regarding a device removal. HPRA Ref: V39451


Olympus Medical Systems Corporation
MAJ-209 SINGLE USE SUCTION VALVE
Advice regarding the use of the device. HPRA Ref: V39199


Olympus Medical Systems Corporation
EVIS LUCERA DUODENOVIDEOSCOPE
Advice regarding changes/updates made to instructions for use. HPRA Ref: V39445


Philips Medical Systems Nederland BV
MultiDiagnost Eleva with Flat Detector, Allura Xper systems and Allura Centron.
Advice regarding a device modification. HPRA Ref: V38925


PREVOR
DIPHOTERINE® MINI-DAP & MICRO-DAP
Advice regarding changes/updates made to instructions for use. HPRA Ref: V39219


Roche
cobas 8000 modular analyzer cobas e810 module
Advice regarding the use of the device. HPRA Ref: V39143


Roche Diabetes Care 
Accu-Chek Insight insulin pump system
Advice regarding a device modification. HPRA Ref: V38073


Roche Diagnostics
ALBP  - Albumin BCP
Advice regarding the use of the device. HPRA Ref: V38948


Siemens
Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica Sample Handler Prime 
Advice regarding a software upgrade. HPRA Ref: V39077


Siemens Healthcare GmbH
syngo.via (syngo.CT Cardiac Function & syngo.CT Cardiac Planning) 
Advice regarding a software upgrade. HPRA Ref: V39308


Siemens Healthcare GmbH
ARTISTE™, ONCOR™ and PRIMUS™ digital linear accelerators
Advice regarding the use of the device. HPRA Ref: V39372


Spinevision
C3 - Anterior Cervical Plate System
Advice regarding a device removal. HPRA Ref: V39297


Thermofisher Scientific
Oxoid CM1106B Brilliance UTI Clarity Agar
Advice regarding a device removal. HPRA Ref: V39425


Tosoh Europe N.V
ST AIA-PACK ACTH, ST AIA-PACK Homocysteine
Advice regarding changes/updates made to instructions for use. HPRA Ref: V39262


Vyaire
enFlow
Advice regarding the use of the device. HPRA Ref: V38918
 


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