Summary of Field Safety Notices- April 2024

Notice type: 3rd Party Publications

Date: 02/05/2024

 

Further Information:
Acutronic Medical Systems AG
fabian HFO Classic and HFOi Ventilator
Advice regarding a software upgrade. HPRA Ref: CRN00F92F


Applied Medical Resources Corporation
Epix UNIVERSAL CLIP APPLIER
Advice regarding a device removal. HPRA Ref: CRN00F3VY


B Braun
ARTERIOFIX ART.-KATH.-SET 20G/80MM
Advice regarding a device removal. HPRA Ref: CRN00F9X8


Beckman Coulter
DxI 9000 Access Immunoassay Analyzer
Advice regarding the use of the device. HPRA Ref: CRN00F954


Becton, Dickinson and Company
BD BACTEC™ MicroMGIT Calibration Vial
Advice regarding a device removal. HPRA Ref: CRN00F7C8


BioRad/DiaMed GmbH
Coombs Anti-IgG, ID-DiaCell I-II-III, LISS/Coombs
Advice regarding the use of the device. HPRA Ref: CRN00F62C


Boston Scientific Neuromodulation Corporation
Vercise Genus™ Implantable Pulse Generator System
Advice regarding a device modification. HPRA Ref:   CRN00F7ZX


Covidien llc
Esoflip Dilation Catheter
Advice regarding a device removal. HPRA Ref: CRN00F8GG


Datascope Corp. Getinge
Cardiosave Intra-Aortic Balloon Pumps
Advice regarding the use of the device. HPRA Ref: V53696


DiaSorin
LIAISON® BRAHMS PCT® II GEN
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00F66T


Dongguan QueenMed Equipment Mfg Co Ltd [EN]
Electrosurgical Electrode
Advice regarding a device removal. HPRA Ref: CRN00F93Y


Draeger Medical Systems, Inc.
Infinity® Acute Care System (M540)
Advice regarding a device modification. HPRA Ref: CRN00F968


DT MedTech
Hintermann Series H3 Total Ankle Replacement (TAR) system
Advice regarding the use of the device. HPRA Ref: CRN00F5XL


Fisher & Paykel Healthcare Ltd
AIRVO2 Humidifier / myAIRVO2 Humidifier - HCP FSN
AIRVO2 Humidifier / myAIRVO2 Humidifier - Distributor FSN
Advice regarding a device removal. HPRA Ref: CRN00F7SG 


HeartSine Technologies, Ltd. (Stryker Medical)
HeartSine samaritan® PAD 350P/360P/450P/500P
Advice regarding the use of the device. HPRA Ref: CRN00F8ZW


In2Bones SAS
NeoFit® screw
Advice regarding a device removal. HPRA Ref: CRN00F8RL


Innomed, Inc.
Cup Removal Starter Instrument-54MM
Advice regarding a device removal. HPRA Ref: CRN00F9VR


Integra Pain Management
Integra Cranial Access Kit without drugs, bits
Advice regarding a device removal. HPRA Ref: CRN00F8QW


Intersurgical Ltd
Various Mapleson F Anaesthetic Breathing Systems
Advice regarding the use of the device. HPRA Ref: CRN00F9QV 


Jenx Ltd
Supine 2/ Multistander 2/ Actuator
Advice regarding a device modification. HPRA Ref:   CRN00F9Y6


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 the use of the device. HPRA Ref: CRN00DZLZ


Laboratoires Vivacy
Stylage M Lidocaine
Advice regarding a device removal. HPRA Ref: CRN00F8XP


Legency Remedies Private Limited
Sodium Chloride Irrigation Solution 0.9% w/v
Sodium Chloride Eye Wash Solution 0.9% w/v
Sodium Chloride Inhalation Solution 0.9 % w/v

Advice regarding a device removal. HPRA Ref: CRN00F8PZ


Leica BioSystems
HistoCore Pegasus and HistoCore Pegasus Plus
Advice regarding the use of the device. HPRA Ref: CRN00F96G


Medtronic B.V US
Software App 9735762 Stealth S8 Application V1.0.1, 1.0.2, 1.0.3, 1.1.0 and 1.2.0
Advice regarding a software upgrade. HPRA Ref: CRN00F90N


Philips Healthcare
Philips MR systems
Advice regarding the use of the device. HPRA Ref: CRN00F6N7


Philips Healthcare (Suzhou) Co., Ltd
Multiva 1.5T
Advice regarding the use of the device. HPRA Ref: CRN00F7C3


Philips Medical Systems
APC (Schneider Electric IT Corporation) UPS for PIC iX
Advice regarding the use of the device. HPRA Ref: CRN00F861


Philips Medizin Systeme Böblingen GmbH
Patient Information Center iX
Advice regarding a software upgrade. HPRA Ref: CRN00F5WR


Randox Laboratories Ltd.
Randox Evidence MULTISTAT
Advice regarding the use of the device. HPRA Ref: CRN00F75G


SCHILLER AG
Tempus LS
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00F8HL


Sleepnet
Sleepnet masks with magnets
Advice regarding the use of the device. HPRA Ref: CRN00F60F


Smith Medical
Cardinal Health Monoject™ Syringes
Advice regarding a device removal. HPRA Ref: CRN00F7ZG


Smith Medical
Portex Blue Line Siliconised PVC Tracheotomy Tube
Advice regarding a device removal. HPRA Ref: CRN00F8LL


Stryker Limerick
EXETER 2.5 I M PLUG
Advice regarding a device removal. HPRA Ref: CRN00F97L


Telefelx Inc
FiberOptix Ultra 8 IAB, Ultra 8 IAB, UltraFlex IAB Catheters
Advice regarding the use of the device. HPRA Ref: CRN00F9K8


Thoratec Corporation
HeartMate 3
Advice regarding the use of the device. HPRA Ref: CRN00F6TZ


Vyaire Medical GmbH
Twin Tube and Twin Tube Probenschlauch
Advice regarding the use of the device. HPRA Ref: CRN00F6Q6


Welch Allyn, Inc.
ProBP 3400, Spot Vision Screener
Advice regarding the use of the device. HPRA Ref: CRN00F9GV


Wright Medical Technology, Inc.
Infinity Resection Guide Adjustment Block
Advice regarding a device removal. HPRA Ref: CRN00F620



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