Summary of Field Safety Notices - October 2019

Notice type: 3rd Party Publications

Date: 11/05/2019

 

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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