Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety communications
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Consumer advice
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Summary of Field Safety Notices - September 2018
Notice type:
3rd Party Publications
Date:
01/10/2018
Further Information:
Abbott
Accelerator APS -FSN 1
Accelerator APS - Attachment
Advice regarding a device modification. HPRA Ref: V37226
Abbott (Wiesbaden)
Alinity i Processing Module
Advice regarding a device modification. HPRA Ref: V37337
Abbott GmbH
Alinity s System
Advice regarding a software upgrade. HPRA Ref: V37054
Abbott GmbH
CentriMag™ Acute Circulatory Support System Motor Model: 201-10002
Advice regarding the use of the device. HPRA Ref: V37231
ACUTRONIC Medical Systems AG
fabian Therapy evolution
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36741
Alcon Laboratories Inc.
Alcon CyPass® Micro-Stent
Advice regarding a device removal. HPRA Ref: V37010
Alere
Alere Triage® NT-pro BNP Test
Advice regarding the use of the device. HPRA Ref: V37114
Axis-Shield Diagnostics Ltd
Alere NT-proBNP for ARCHITECT Controls
Advice regarding a device removal. HPRA Ref: V37284
B. Braun Medical Limited
220-240V Unit Cable (power cord) for Infusomat fmS, Infusomat P and SpaceCover
Advice regarding a device removal. HPRA Ref: V37283
Bauch& Lomb INC
Stellaris Elite Single Port Vitrectomy Cutters
Advice regarding a device removal. HPRA Ref: V36715
Baxter
AK 98
Advice regarding the use of the device. HPRA Ref: V37278
Beckman Coulter Ireland Inc
Lipase OSR6x30, Uric Acid OSR6x98, HDL-Cholesterol OSR6x87, Enzymatic Creatinine OSR6x204
Advice regarding a device modification. HPRA Ref: V36847
Beekley Corporation
S-SPOT, TomoSPOT, O-SPOT
Advice regarding a device removal. HPRA Ref: V36912
BioFire Diagnostics
BioFire® FilmArray® Blood Culture Identification Panel
Advice regarding the use of the device. HPRA Ref: V37232
Caesare Medical Electronics Limited
T34 Ambulatory Syringe Pump
Advice regarding the use of the device. HPRA Ref: V35346
Cardiac Pacemaker Inc – A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidiary of Boston Scientific Corporation
ACCOLADE™ & ACCOLADE™ MRI, PROPONENT™ & PROPONENT™ MRI, ESSENTIO™ & ESSENTIO™ MRI, VISIONIST™ X4 & VALITUDE™ X4 - FSN 1
ACCOLADE™ & ACCOLADE™ MRI, PROPONENT™ & PROPONENT™ MRI, ESSENTIO™ & ESSENTIO™ MRI, VISIONIST™ X4 & VALITUDE™ X4 - FSN 2
Advice regarding the use of the device. HPRA Ref: V37235
CooperSurgical Inc
Lone Star Single-Use Elastic Stays
Advice regarding a device removal. HPRA Ref: V37298
Covidien LLC
Puritan Bennett™ 980 (PB980) ventilator series
Advice regarding a software upgrade. HPRA Ref: V37345
Dr. Mach GmbH & Co. KG
Dr. Mach OT Light with Heavy Central Axis
Advice regarding the use of the device. HPRA Ref: V36699
Endologix International Holdings B.V.
AFX EndoVascular AAA System
Advice regarding the use of the device. HPRA Ref: V37351
Harvest Healthcare Ltd.
HA200 Unipump - Opal, Opal Plus, Salisbury and Prime Overlay Mattresses and HH20 Active Seat System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34743
Intuitive Surgical Inc
da Vinci® EndoWrist® Monopolar Curved Scissors
Advice regarding the use of the device. HPRA Ref: V36898
IVT Imuno, s.r.o.
AB0 bedside kit
Advice regarding the use of the device. HPRA Ref: V36232
Leica Biosystems
Slide Labeler (Zebra) used with BOND-MAX/BOND-III
Advice regarding the use of the device. HPRA Ref: V37180
Leica Microsystems
Leica M525 F20
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36911
Maquet Critical Care AB
SoKINOX/SERViNO NO Delivery and Monitoring System
Advice regarding a software upgrade. HPRA Ref: V37264
Mast Group Ltd.
AUGMENTIN 32mg/L PLATE, MPM-AUG32
Advice regarding a device modification. HPRA Ref: V36073
medica Medizintechnik GmbH
THERA-Trainer balo /THERA-Trainer verto
Advice regarding a device modification. HPRA Ref: V36701
Oridion Medical 1987 Ltd.
Capnostream™ 20 and Capnostream™ 20p Bedside Patient Monitors
Advice regarding a software upgrade. HPRA Ref: V36804
Orthofix SRL
Drill Bits
Advice regarding a device removal. HPRA Ref: V37406
Ovesco Endoscopy
AWC-Additional Working Channel
Advice regarding a device removal. HPRA Ref: V37107
Randox Laboratories Limited
Liquid Cardiac Control - FSN
Liquid Cardiac Control - Attachment
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37379
Roche
Accu-Chek Inform II, cobas h 232, CoaguChek Pro II, CoaguChek XS Plus / XS Pro systems
Advice regarding a software upgrade. HPRA Ref: V36909
Roche Diagnostics GmBH
MagNA Pure 24 System
Advice regarding a software upgrade. HPRA Ref: V35702
Roche Diagnostics GmBH
Elecsys FT4 III
Advice regarding the use of the device. HPRA Ref: V37320
SEERS Medical Ltd.
SEERS Medical Bariatric Drop End Couches
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36951
Stryker
XIA 3 Degen Tray / XIA 3 Rod and Cross Connector Tray / French Bender
Advice regarding the use of the device. HPRA Ref: V37191
Stryker Leibinger GmbH&Co KG
HydroSet Injectable HA Bone Substitute
Advice regarding a device removal. HPRA Ref: V37276
Stryker Medical
Altrix model 8001
Advice regarding a device removal. HPRA Ref: V37395
Varian Medical Systems
TrueBeam, TrueBeam STx, VitalBeam and EDGE treatment delivery systems
Advice regarding a software upgrade. HPRA Ref: V36874
Welch Allyn Inc
Connex Spot Monitor (CSM) with Masimo SpO2 option
Advice regarding a software upgrade. HPRA Ref: V36322
« Back
Date Printed: 05/12/2023