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Summary of Field Safety Notices - October 2019
Notice type:
3rd Party Publications
Date:
05/11/2019
Further Information:
Abbott
03R65-01: Alinity i Processing Module 03R67-01: Alinity c Processing Module
Advice regarding a device modification. HPRA Ref: 41478
Allergan
Allergan XEN Glaucoma Treatment System
Advice regarding a device removal. HPRA Ref: V41899
Arjo
Akron Tilt Table
Advice regarding a device modification. HPRA Ref: V41710
Baxter
Prismaflex Control Units
Advice regarding a software upgrade. HPRA Ref: V41848
Baylis
RoeFlex Transseptal Guiding Sheath
Advice regarding a device removal. HPRA Ref: V41844
BD BARD
Bard® MaxCore® Disposable Core Biopsy Instrument
Advice regarding a device removal. HPRA Ref: V41968
Biomerieux INC
VIDAS 3
Advice regarding the use of the device. HPRA Ref: V41930
bioMérieux SA
Cetrimide Agar
Advice regarding a device removal. HPRA Ref: V41974
Boston Scientific
"Emerge™ Monorail™, NC Emerge™ Monorail PTCA Dilation Catheters, Guidezilla™ II Guide Extension Catheter Agent™ Paclitaxel Coated PTCA Balloon Catheters"
Advice regarding a device removal. HPRA Ref: V41773
Bruin Biometrics
SEM Scanner 200
Advice regarding a device removal. HPRA Ref: V41394
Change Healthcare
Canada Company McKesson Radiology Manager
Advice regarding a software upgrade. HPRA Ref: V41792
ConvaTec
Convex Two-Piece Skin Barriers i.e. Natura /Surfit
Advice regarding the use of the device. HPRA Ref: V41499
HandyVac™, UnoMeter™ 500
Advice regarding a device removal. HPRA Ref: V41652
Cook Medical
Torcon NB® Advantage Catheter
Advice regarding a device removal. HPRA Ref: V41865
Dako
Autostainer Syringe Tray
Advice regarding the use of the device. HPRA Ref: V41952
Edwards LifeSciences
EZ Glide Aortic Cannula
Advice regarding a device removal. HPRA Ref: V41902
Flexicare
BritePro Solo Laryngoscope handles and blades (Macintosh, Miller)
Advice regarding a device removal. HPRA Ref: V41893
Flowonix
Prometra Programmable Pump
Advice regarding the use of the device. HPRA Ref: V41135
GE Healthcare
Achilles Express; Achilles Insight
Advice regarding a device modification. HPRA Ref: V41582
Hain Lifescience GmbH
Substrate Buffer (SUB-D)
Advice regarding the use of the device. HPRA Ref: V41509
In2Bones
Medial targeting guide-Right / Left
Advice regarding a device removal. HPRA Ref: V41643
Neofuse ankle fusion system- Locking screws
Advice regarding a device removal. HPRA Ref: V41772
INNOTERE
INNOTERE Paste-CPC, 3 cc
Advice regarding a device removal. HPRA Ref: V41748
Karl Storz Endoskope SE
C-MAC® video laryngoscopes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41880
Medtronic
SynchroMed® II Implantable Infusion Pump
Advice regarding a device removal. HPRA Ref: V41764
IPGs/CRTs/ICDs and Carelink
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V41657
Medtronic Inc.
CareLink Programmer; CareLink Encore Programmer
Advice regarding a software upgrade. HPRA Ref: V37585
Origen Biomedical
DMSO, O-Wrap, TissueVault
Advice regarding a device removal. HPRA Ref: V41703
Ortho Clinical Diagnostics Inc. U.S.
ORTHO VISION and VISION Max Analyzers
Advice regarding a software upgrade. HPRA Ref: V41690
Philips Healthcare
Ingenuity CT, Ingenuity Core, Ingenuity Core 128, Brilliance 64, iCT, iCT SP, IQon, Ingenuity TF PET/CT, Vereos PET/CT
Advice regarding a software upgrade. HPRA Ref: V40716
Philips Medical Systems
HeartStart XL+ Defibrillator/Monitor
Advice regarding a device modification. HPRA Ref: V41975
HeartStart XL+ Defibrillator/Monitor
Advice regarding a device modification. HPRA Ref: V41978
Randox
Liquid Cardiac Controls
Advice regarding a device modification. HPRA Ref: V41637
Roche Diagnostics
VENTANA HE 600 System
Advice regarding a device modification. HPRA Ref: V41716
Cardiac Pipettes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41786
Stryker
Smoke Evacuation Pencils
Advice regarding a device removal. HPRA Ref: V41704
Teleflex
"WECK® Auto Endo5® Automatic Hem-o-lok® Clip Appliers
Hem-o-lok® Clip Appliers
Hem-o-lok® Clip Appliers"
Advice regarding a device removal. HPRA Ref: V41682
Arrow® EZ-IO® Intraosseous Vascular Access Needle Sets
Advice regarding a device removal. HPRA Ref: V41585
Teleflex Medical
Various Sheridan Endotracheal Tubes
Advice regarding a device removal. HPRA Ref: V40185
Vygon (UK) Ltd
V-GREEN NARROW BORE+CLAMP IV EXTENSION LINE
Advice regarding a device removal. HPRA Ref: V41787
Zimmer Biomet
Various Zimmer - Biomet Products
Advice regarding a device removal. HPRA Ref: V41567
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Date Printed: 19/04/2024