My HPRA: Register

Summary of Field Safety Notices - May 2019

Notice type: 3rd Party Publications

Date: 06/06/2019

  

Further Information:
Abbott
ARCHITECT c4000 / c8000 / c16000 Mixer
Advice regarding the use of the device. HPRA Ref: V39936


Abbott
MitraClip XTR Delivery system
Advice regarding the use of the device. HPRA Ref: V39984


Abbott
ARCHITECT Complement C3; Immunoglobulin A; Immunoglobulin G;Immunoglobulin M; Apolipoprotein A1; Complement C4; Haptoglobin; Apolipoprotein B; Transferrin
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40111


Abbott
Alinity c Complement C3; Immunoglobulin A; Immunoglobulin G; Immunoglobulin M; Apolipoprotein A1; Complement C4; Haptoglobin; Apolipoprotein B; Transferrin Reagent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40112


Abbott
Alinity ci-series System Control Module
Advice regarding a software upgrade. HPRA Ref: V40155


Abbott
Alinity i BNP Calibrators; Alinity i BNP Controls
Advice regarding a device removal. HPRA Ref: V40198


Abbott Laboratories
ARCHITECT BNP Calibrators; ARCHITECT BNP Controls
Advice regarding a device removal. HPRA Ref: V40196


ArjoHuntleigh AB
Arjo System 2000 Bath
Advice regarding a device modification. HPRA Ref: V40142


Baxter Healthcare SA
Clear Link Extension Set_FSN Issued_Product Recall
Advice regarding a device removal. HPRA Ref: V39837


Beaver-Visitec International Inc.
BVI Visitec®VisiWipe or Merocel® ophthalmic instrument wipes and/or wicks and corneal light shield sponge products 
Advice regarding the use of the device. HPRA Ref: V39887


Beckman Coulter Inc 
Access Free T3, Total T3, Free T4, GI Monitor (GI Mon),Thyroglobulin ,Thyroglobulin Antibody II
Advice regarding a device modification. HPRA Ref: V39946


Cardinal Health
Monoject needles and cannulas
Advice regarding a device removal. HPRA Ref: V39908


Change Healthcare Israel Ltd.
Horizon/McKesson Cardiology Hemo
Advice regarding a software upgrade. HPRA Ref: V40079


Edwards Lifesciences LLC
Swan-Ganz® True Size Flow-Directed Monitoring Cath
Advice regarding the use of the device. HPRA Ref: V39994


Gambro Industries France 
Prismaflex M100 set, HF1000 set, M150 set, ST150 set, TPE2000 set, ST100 set, HP-X set, OXIRIS S, Septex set   
Advice regarding the use of the device. HPRA Ref: V39968


Hain Lifescience GmbH
FluoroSoftware IVD used with FluoroCyclers 12 & 96
Advice regarding a software upgrade. HPRA Ref: V40207


Hyaltech Ltd
Visthesia 1.0%
Advice regarding a device removal. HPRA Ref: V39848


Maquet Cardiopulmonary GmbH
QUADROX-i Neonatal Microporous Membrane Oxygenator
Advice regarding the use of the device. HPRA Ref: V40028


MAQUET SAS
Volista STANDOP, Volista TRIOP
Advice regarding the use of the device. HPRA Ref: V39833


Medacta International
GMK UNI Femur sizes 3 & 4
Advice regarding the use of the device. HPRA Ref: V38897


Medtronic
Covidien Emprint™ Percutaneous Antenna with Thermosphere™ Technology
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32847


Medtronic
Sherpa Active 6F Guide Catheter
Advice regarding a device removal. HPRA Ref: V39302


Medtronic Inc
Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ cardiac resynchronization therapy pacemakers (CRT-P)
Advice regarding the use of the device. HPRA Ref: V39970


Medtronic Inc.
My Therapy App for Sacral Neuromodulation Therapy (A510 Clinician Application - Medtronic’s Smart Programmer).
Advice regarding the use of the device. HPRA Ref: V40091


Medtronic Navigation, Inc.
O-arm® 1000 Imaging System
Advice regarding a device modification. HPRA Ref: V40087


Pfizer
ThermaCare Lower Back & Hip Heatwraps
Advice regarding a device removal. HPRA Ref: V39997


Phadia AB 
EliA RF IgM Well
Advice regarding a device removal. HPRA Ref: V40082


Philips
Philips SureSigns VS3/VS4 Monitors
Advice regarding a software upgrade. HPRA Ref: V39873


R82
Wombat Living size 3
Advice regarding a device modification. HPRA Ref: V39539


Radiometer
ABL800 analyzers
Advice regarding a software upgrade. HPRA Ref: V36192


Randox Laboratories Ltd
HUMAN ASSAYED MULTI-SERA Level 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40180


Rifton
K310 & K320 TRAM, K660 E-Pacer
Advice regarding a device modification. HPRA Ref: V39746


Roche Diagnostics
BILT3, IGM-2, and LACT2
Advice regarding the use of the device. HPRA Ref: V38105


Roche Diagnostics GmbH
Tina-quant IgA Gen.2
Advice regarding the use of the device. HPRA Ref: V40152


Sacci Ryggsäckar AB 
Infusion Thermo Bag CE
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40199


SenoRx Inc / BD / Bard
EnCor® Breast Biopsy Probe
EnCor® Breast Biopsy Probe-Update
Advice regarding the use of the device. HPRA Ref: V39925


SenTec AG
Membrane Changers and their Inserts used with V-Sign™ and OxiVenT™ Sensors (SenTec Digital Monitoring System- SDMS)
Advice regarding a device removal. HPRA Ref: V40044


Siemens Healthcare GmbH; Business Area Advanced Therapies
ARTIS zee and AXIOM Artis
Advice regarding a device modification. HPRA Ref: V40201


Teleflex
Sheridan Endotracheal Tubes
Advice regarding a device removal. HPRA Ref: V40185


Tristel Solutions Ltd
Tristel Rinse Wipe
Advice regarding the use of the device. HPRA Ref: V39875


Willy Rüsch GmbH
Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
Advice regarding a device removal. HPRA Ref: V39698


Xtant Medical
Calix P and T Lumbar Plasma Coated Implants
Advice regarding a device removal. HPRA Ref: V38894
 

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