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Summary of Field Safety Notices- December 2023
Notice type:
3rd Party Publications
Date:
04/01/2024
Further Information:
Amity Ltd
Virusolve+ Concentrate and Virusolve+ RTU
Advice regarding the use of the device. HPRA Ref: CRN00DZTJ
Anhui Anyu Latex Products Co., Ltd
Sterile Latex Surgical Gloves, MEDISTOCK brand
Advice regarding a device removal. HPRA Ref: CRN00DXQL
B. Braun
Introducer Needle
Advice regarding a device removal. HPRA Ref: CRN00F0YH
Bard Peripheral Vascular, Inc.
Bard® Mission® Disposable Core Biopsy Kit
Advice regarding a device removal. HPRA Ref: CRN00DYSL
Baxter Healthcare Ltd
Q-stress 6 and Xscribe 6
Advice regarding a software upgrade. HPRA Ref: CRN00F04Q
Cardiac Pacemaker Inc
Model 3120 ZOOM PRM with Model 2892 Software
Advice regarding the use of the device. HPRA Ref: CRN00DZPP
Cordis Cashel
OPTEASE™ Retrievable VCF and retrieval Catheter
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DYMK
Datex-Ohmeda, Inc.
EVair medical air compressor, Evair 03
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00F12W
Ecolab Deutschland GmbH
Incidin OxyWipe S and Incidin OxyFoam S
Advice regarding a device removal. HPRA Ref: CRN00DZ84
FUJIFILM medwork GmbH
Polypektomy snare (POL1-X1-Series)
Advice regarding a device removal. HPRA Ref: CRN00F0TP
Gyrus ACMI, Inc.
SOLTIVE Single-use Laser Fibers
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00F009
Integra LifeSciences Mansfield
CODMAN® VPV® SYSTEM
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DZRR
Intuitive Surgical Inc.
SureForm 45 / SureForm 45 Curved-Tip / SureForm 60
Advice regarding a device removal. HPRA Ref: V54049
Intuitive Surgical, Inc.
Instrument Arm Drape (da Vinci Xi and X surgical systems)
Advice regarding the use of the device. HPRA Ref: CRN00DW24
Invacare REA AB
Invacare Dolomite Gloss
Advice regarding a device modification. HPRA Ref: CRN00DY5R
KARL STORZ SE & Co. KG
Antrum Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Optical Scissor, Working Insert, with steering lever
Advice regarding a device removal. HPRA Ref: CRN00DZLZ
Löwenstein Medical Technology GmbH + Co. KG
LUISA, TIVAN LS, Life One (LM150TD) ventilators
Advice regarding a software upgrade. HPRA Ref: CRN00F0WC
Maquet Cardiopulmonary GmbH
HLS Set Advanced 5.0 / 7.0
Advice regarding the use of the device. HPRA Ref: CRN00F0WZ
Maquet Critical Care AB
Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00F045
Medex
Secufill
Advice regarding a device removal. HPRA Ref: CRN00F0SD
Medtronic Navigation Inc.
Sterile Percutaneous Reference Pin (Model #9733235 and 9733236)
Advice regarding a device removal. HPRA Ref: CRN00F02Z
Medtronic Navigation Inc.
StealthStationTM Cranial and SynergyTM Cranial
Advice regarding a software upgrade. HPRA Ref: V48047
Medtronics
INVOS PM7100 Resuable Sensor Cables
Advice regarding a device removal. HPRA Ref: CRN00F12F
Megadyne Medical Products, Inc.
MEGADYNE™ MEGA SOFT™ Universal and Universal Plus Reusable Patient Return Electrodes
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00F04M
Olympus Medical Systems Corporation
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
Advice regarding the use of the device. HPRA Ref: CRN00DZPZ
Olympus Medical Systems Corporation
Single Use Distal Cover MAJ-2315
Advice regarding the use of the device. HPRA Ref: CRN00F0H8
Philips Medical Systems Nederland B.V.
Philips BrightView, X, XCT
Advice regarding the use of the device. HPRA Ref: CRN00DZV1
Philips Medical Systems Nederland B.V.
Philips BrightView, X, XCT
Advice regarding the use of the device. HPRA Ref: CRN00F0RC
Philips Medical Systems Nederland BV
Philips Azurion
Advice regarding a software upgrade. HPRA Ref: CRN00F06T
Philips Medizin Systeme Böblingen GmbH
Patient Information Center iX
Advice regarding a software upgrade. HPRA Ref: CRN00DZSQ
QuidelOrtho (Ortho Clinical Diagnostics Inc)
RTHO VISION and VISION Max Analyzers for BioVue
Advice regarding the use of the device. HPRA Ref: CRN00DYSK
Randox Laboratories Ltd
Copper
Advice regarding a device modification. HPRA Ref: CRN00DZCQ
Siemens Healthcare Diagnostics Inc
Atellica CH Immunoglobulin M_2 (IgM_2)
Advice regarding the use of the device. HPRA Ref: CRN00F0L4
Stryker Joint Replacement
Scorpio, Duracon, PCA, Trident
Advice regarding a device removal. HPRA Ref: CRN00F027
Thuasne Deutschland GmbH
Sprystep Plus, Sprystep KAFO, Sprystep Vector
Advice regarding the use of the device. HPRA Ref: CRN00DZ9N
VBM Medizintechnik GmbH
Manujet III
Advice regarding a device removal. HPRA Ref: CRN00DZZS
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Date Printed: 30/04/2024