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 - November 2021
Notice type:
3rd Party Publications
Date:
02/12/2021
Product name or type:
Further Information:
Summary of Field Safety Notices - November 2021
Abbott Medical
Amplatzer Steerable Delivery Sheath
Advice regarding the use of the device. HPRA Ref: V47961
Abbott Laboratories - US
ARCHITECT c8000, c16000, i2000SR, i1000SR
Advice regarding the use of the device. HPRA Ref: V47547
Abbott Laboratories -Abbott Park
ARCHITECT c4000 & ARCHITECT i2000
Advice regarding the use of the device. HPRA Ref: V47546
AMO Ireland
iDESIGN® Refractive Studio & CATALYS™ Precision Laser Operating Systems
Advice regarding a software upgrade. HPRA Ref: V47973
Argon Medical
SuperCore Semi-Automatic Biopsy Instrument
Advice regarding a device removal. HPRA Ref: V47750
B.Braun Medical
NEXADIA monitor Set, NEXADIA monitor 2 Set
Advice regarding a software upgrade. HPRA Ref: V48005
Baxter Healthcare SA
PrisMax, V2
Advice regarding a software upgrade. HPRA Ref: V47610
bioMérieux Inc
RAPID 20 E™ (Reference 20701)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47931
bioMérieux SA
VIDAS Immuno-Assays (Multiple references)
Advice regarding the use of the device. HPRA Ref: V47861
Canterbury Scientific Limited
Hemoglobin F and A2 Control
Advice regarding a device modification. HPRA Ref: V47941
Coloplast A/S
Supraflow® supra-pubic drainage set
Advice regarding a device removal. HPRA Ref: V47213
ConvaTec Limited
Avelle™ Negative Pressure Wound Therapy Pump
Advice regarding a device removal. HPRA Ref: V48013
Cordis
SUPER TORQUE® MB Angiographic Catheters (with Marker Bands) - FSN2
Advice regarding the use of the device. HPRA Ref: V47051
D.J.O. LLC
Chattanooga Ultrasound Gels and Lotions
Advice regarding a device removal. HPRA Ref: V47715
Data Innovations LLC
Instrument Manager
Advice regarding a software upgrade. HPRA Ref: V47622
Datex-Ohmeda, Inc. (GE Healthcare)
Giraffe Incubator, Giraffe Incubator Carestation, Giraffe OmniBed and Giraffe Omnibed Carestation
Advice regarding a device modification. HPRA Ref: V48082
DIXI Medical S.A.S.
MICRODEEP intracerebral electrode
Advice regarding a device removal. HPRA Ref: V48072
EKF-diagnostic GmbH
ß-Hydroxybutyrate LiquiColor®
Advice regarding a device removal. HPRA Ref: V46984
Fannin Ltd.
W11050 Columbia Blood agar
Advice regarding a device removal. HPRA Ref: V47907
FUJIFILM Irvine Scientific
Vitrification Freeze Kit
Advice regarding the use of the device. HPRA Ref: V47658
GE healthcare Finland Oy
Centricity™ High Acuity Anesthesia / Critical Care
Advice regarding a software upgrade. HPRA Ref: V47896
GE Helathare
Centricity Universal Viewer Zero Footprint client
Advice regarding the use of the device. HPRA Ref: V47985
Getinge
Datascope Cardiosave Hybrid and Cardiosave rescue IABP
Advice regarding a device modification. HPRA Ref: V48145
Intelerad Medical Systems
Incorporated IntelePACS
Advice regarding a software upgrade. HPRA Ref: V47860
Ivor Shaw Ltd. (t/a Pennine Healthcare)
Nasogastric devices (Ryles Tubes, Levins Tubes and Feeding Tubes), Suction Catheters, Rectal Tubes, Nelaton catheters
Advice regarding the use of the device. HPRA Ref: V48049
Leica Microsystems (Schweiz) AG
Leica M220 F12
Advice regarding a device modification. HPRA Ref: V47927
Life Technologies Corporation, a part of Thermo Fisher Scientific
TaqPath™ COVID-19 CE-IVD RT-PCR Kit
Advice regarding the use of the device. HPRA Ref: V47951
Maquet Cardiopulmonary GmbH
Customized tubing sets
Advice regarding a device removal. HPRA Ref: V47856
Medline
Sterile Surgical Gowns
Advice regarding the use of the device. HPRA Ref: V47749
Sterile Procedure Trays containing Surgical Gowns
Advice regarding the use of the device. HPRA Ref: V47922
Medtronic
Abre Venous Self-Expanding Stent system
Advice regarding the use of the device. HPRA Ref: V47972
Synergy Cranial and Stealthstation Cranial
Advice regarding a software upgrade. HPRA Ref: V48047
Medtronic Inc.
Wireless Rechargers for InterStim Micro, Activa RC, RestoreUltra and RestoreSensor implantable neurostimulators - FSN 1
Advice regarding the use of the device. HPRA Ref: V48067
Wireless Rechargers for InterStim Micro, Activa RC, RestoreUltra and RestoreSensor implantable neurostimulators - FSN 2
Advice regarding the use of the device. HPRA Ref: V48067
Wireless Rechargers for InterStim Micro, Activa RC, RestoreUltra and RestoreSensor implantable neurostimulators - FSN 3
Advice regarding the use of the device. HPRA Ref: V48067
MOOG
FreeGo Enteral Feeding Pump
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47863
Olympus Medical Systems Corporation
Forceps/Irrigation plug (Isolated type) - MAJ891
Advice regarding the use of the device. HPRA Ref: V48131
PAJUNK GmbH Medizintechnologie
SPROTTE NRFit
Advice regarding a device removal. HPRA Ref: V47915
Philips Medical Systems
BV Endura, BV Pulsera, Veradius Unity
Advice regarding the use of the device. HPRA Ref: V48085
Philips Medical Systems Nederland BV
Philips Allura Xper and Azurion systems
Advice regarding the use of the device. HPRA Ref: V47879
Randox Laboratories Limited
Randox Cholesterol
Advice regarding a device removal. HPRA Ref: V47711
Randox Evidence Investigator
Advice regarding a software upgrade. HPRA Ref: V47892
Siemens
Biograph mCT
Advice regarding the use of the device. HPRA Ref: V47890
The Binding Site Group ltd
Freelite® Human Lambda Free Kit for use on the SPA
Advice regarding the use of the device. HPRA Ref: V47669
Thermo Fisher Scientific
Thermo Scientific™ Campylobacter Test
Advice regarding a device removal. HPRA Ref: V48043
« Back
Date Printed: 14/11/2024