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FSN Summary Sheet - July 2024
Notice type:
3rd Party Publications
Date:
02/08/2024
Further Information:
Summary of Field Safety Notices- July 2024
Dt MedTech
Hintermann Series H3 Total Ankle Replacement System
Advice regarding the use of the device. HPRA Ref: CRN00F5XL
Boston Scientific Neuromodulation Corporation
Vercise Genus™ Implantable Pulse Generator System
Advice regarding a device modification. HPRA Ref:CRN00F7ZX
Inspiration Healthcare
SLE6000 Infant ventilator
Advice regarding a device modification. HPRA Ref:CRN00FH65
Philips Respironics, Inc.
BiPaP Ventilators
Advice regarding the use of the device. HPRA Ref:CRN00FHCP
Welch Allyn, Inc.
Braun Thermoscan® Pro 6000
Advice regarding the use of the device. HPRA Ref:CRN00FHNV
Schiller Medical
DEFIGARD Touch-7
Advice regarding a software upgrade. HPRA Ref:CRN00FHPQ
Siemens Healthcare GmbH
Luminos Agile
Advice regarding the use of the device. HPRA Ref:CRN00FHQH
Medtronic Xomed, Inc.
NIM™ Vital Nerve Monitoring System
Advice regarding a software upgrade. HPRA Ref:CRN00FHSX
GE Healthcare Finland Oy
Centricity High Acuity Anesthesia
Advice regarding a software upgrade. HPRA Ref:CRN00FHW7
BioFire Diagnostics, LLC
BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel
Advice regarding the use of the device. HPRA Ref:CRN00FHXY
Ventana Medical Systems Inc.
VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary
Advice regarding a device removal. HPRA Ref:CRN00FJ7L
Argon Medical Devices, Inc. USA
BioPince™, BioPinceUltra™ and TruCore™ II Automatic Biopsy Instruments
Advice regarding a device removal. HPRA Ref:CRN00FJ8S
Life Technologies Corporation
Oncomine Dx Express Test Panel
Advice regarding the use of the device. HPRA Ref:CRN00FJ9K
Beckman Coulter
DxI 9000 Access Immunoassay Analyzer
Advice regarding a device modification. HPRA Ref: CRN00FJJW
Trilogy EVO
Philips Respironics, Inc.
Advice regarding a software upgrade. HPRA Ref:CRN00FJMN
RAL Diagnostics
RAL Diff-Quik™ Fixative solution
Advice regarding the use of the device. HPRA Ref:CRN00FJRN
Boston Scientific Neuromodulation Corporation
WaveWriter Alpha™ IPG Kit
Advice regarding a device modification. HPRA Ref:CRN00FJRY
Maquet Cardiopulmonary GmbH
products that contain a vacuum-tight version of a Venous Hardshell Cardiotomy Reservoir
Advice regarding a device removal. HPRA Ref:CRN00FJRZ
Philips Goldway (Shenzhen) Industrial Inc.
HeartStart Intrepid Monitor/Defibrillator
Advice regarding the use of the device. HPRA Ref:CRN00FJSQ
Medtronic Inc.
CareLink Programmer
Advice regarding a software upgrade. HPRA Ref:CRN00FJZ0
Beckman Coulter
DxI 9000 Access Immunoassay Analyzer
Advice regarding a device modification. HPRA Ref:CRN00FK07
Philips Medical Systems Nederland BV
Philips Azurion R1.x
Advice regarding a software upgrade. HPRA Ref:CRN00FK1Z
Becton Dickinson and Company
BD BACTEC™ MGIT™ 960 PZA Kit
Advice regarding a device removal. HPRA Ref:CRN00FK28
Exmoor Plastics Limited
Aural Ventilation Tubes
Advice regarding a device removal. HPRA Ref:CRN00FK66
Change Healthcare Canada Company
Change Healthcare Cardiology
Advice regarding the use of the device. HPRA Ref:CRN00FK6S
Exmoor Plastics Limited
Silicone Sheets, Discs and Strips
Advice regarding the use of the device. HPRA Ref:CRN00FK82
Convatec Infusion Care
Kaltostat
Advice regarding a device removal. HPRA Ref:CRN00FKJ3
Zevex Inc. (doing business as Moog Medical Devices)
FreeGo Pump
Advice regarding the use of the device. HPRA Ref:CRN00FKKT
Covidien LLC
McGRATH MAC Video Laryngoscope
Advice regarding a device removal. HPRA Ref:CRN00FKTJ
Abbott Medical
HeartMate 3 System Controller 1
Advice regarding the use of the device. HPRA Ref:CRN00FKW7
Abbott Medical
HeartMate 3 System Controller 2
Advice regarding the use of the device. HPRA Ref:CRN00FKW7
Medline International France SAS
Delivery sets
Advice regarding the use of the device. HPRA Ref:CRN00FKXX
Zoll Medical Corporation
Powerheart® G5 AED, Semi-Automatic, G5S
Advice regarding the use of the device. HPRA Ref:CRN00FL2H
Löwenstein Medical Technology
Luisa Ventilators LM150TD
Advice regarding a software upgrade. HPRA Ref:CRN00FL7S
Medtronic Xomed, Inc.
NIM Contact™ EMG Reinforced Endotracheal Tubes and NIM™ Standard EMG Reinforced Endotracheal Tubes
Advice regarding a device removal. HPRA Ref:V51301
Medtronic Inc.
Viva™, Brava™, Evera™, Evera MRI, Visia AF™, Visia AF MRI™, Primo MRI™, Mirro MRI™ , Claria MRI™, Amplia MRI™, Compia MRI™ CRT-Ds and ICDs
Advice regarding a software upgrade. HPRA Ref:V55139
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Date Printed: 09/11/2024