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Summary of Field Safety Notices - July 2022
Notice type:
3rd Party Publications
Date:
03/08/2022
Further Information:
Abbott
Assurity/Endurity Pacemakers FSN 1
Assurity/Endurity Pacemakers FSN 2
Advice regarding a device removal. HPRA Ref: V52079
B.Braun Melsungen AG
SpaceCom
Advice regarding a software upgrade. HPRA Ref: V50448
Baxter Healthcare
Digital Communication Module Kit (PrisMax)
Advice regarding a device modification. HPRA Ref: V52136
Beijing Lepu Medical Technology Co., Ltd.
Disposable sampling swab
Advice regarding the use of the device. HPRA Ref: V51339
Beijing Lepu Medical Technology Co., Ltd.
Sample treatment solution
Advice regarding the use of the device. HPRA Ref: V51399
Benoit Systemes
Light Drive 2.1
Advice regarding a device modification. HPRA Ref: V52050
bioMérieux SA
NucliSENS easyMAG Magnetic Silica
Advice regarding a device modification. HPRA Ref: V51910
Boston Scientific
EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD
Advice regarding a software upgrade. HPRA Ref: V52102
Cardiac Pacemaker Inc
ZOOM Latitude Programmer
Advice regarding a software upgrade. HPRA Ref: V51994
DePuy Synthes
ATTUNE™ Measured Sizing & Rotation Guide Instrument
Advice regarding a device modification. HPRA Ref: V51772
GE Healthcare
Tables used with CT, PET and NM systems
Advice regarding a device modification. HPRA Ref: V52006
GE Healthcare
Centricity Universal Viewer
Advice regarding a software upgrade. HPRA Ref: V52139
GE Healthcare Finland Oy
Centricity High Acuity (CHA) C.C and Anesthesia
Advice regarding a device modification. HPRA Ref: V52008
Gelita Medical GmbH
GELITA SPON, GELITA ENT devices FSN 1
GELITA SPON, GELITA ENT devices FSN 2
Advice regarding a device removal. HPRA Ref: V52116
Hamilton Medical AG
HAMILTON-C6
Advice regarding the use of the device. HPRA Ref: V51898
Leica Biosystems Newcastle Ltd
BOND Enzyme Pretreatment Kit - AR9551
Advice regarding changes/updates made to instructions for use. HPRA Ref: V51787
LifeScan Europe GmbH
OneTouch Reveal Insulin Mentor mobile application
Advice regarding the use of the device. HPRA Ref: V52054
Mallinckrodt Manufacturing LLC
INOmax DSIR
Advice regarding the use of the device. HPRA Ref: V51891
Maquet Cardiopulmonary GmbH
HLS Set Advanced 5.0, HLS Set Advanced 7.0
Advice regarding a device removal. HPRA Ref: V52053
Meden-lnmed
Lifteo ELA, Lifteo MLA, Diana II ELA, Diana II MLA
Advice regarding a device modification. HPRA Ref: V52080
Medtronic
EverFlex™ Self-Expanding Peripheral Stent with Entrust ™ Delivery System
Advice regarding the use of the device. HPRA Ref: V51752
Medtronic Inc.
Vanta LT Clinician Programmer Application
Advice regarding the use of the device. HPRA Ref: V52153
Medtronic Inc.
Vanta LT Clinician Programmer Application.
Advice regarding the use of the device. HPRA Ref: V52161
Raffin Medical
Raffin Sets
Advice regarding a device removal. HPRA Ref: V51729
Respironics California, LLC
V60/V60 Plus/V680 Ventilators
Advice regarding a device modification. HPRA Ref: V50696
Roche
cobas pure e 402 analytical unitcobas e 801 analytical unitcobas pure sample supply unit cobas pro sample supply unit cobas pro SSU cobas 8000 core unit
Advice regarding a software upgrade. HPRA Ref: V51999
Siemens Healthcare Diagnostics Inc. (NY)
Atellica CH Iron_2
Advice regarding a software upgrade. HPRA Ref: V51805
Siemens Healthcare GmbH
AXIOM Sensis XP/ Sensis/ Sensis Lite/ Vibe Combo
Advice regarding the use of the device. HPRA Ref: V52005
Sysmex Corporation Japan
Fluorocell PLT
Advice regarding a device removal. HPRA Ref: V50372
Thermo Fisher Scientific
Remel RapID™ NF System
Advice regarding a device removal. HPRA Ref: V52101
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Date Printed: 29/11/2022