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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
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Date Printed: 19/04/2024