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Summary of Field Safety Notices - May 2024
Notice type:
3rd Party Publications
Date:
05/06/2024
Further Information:
Alcon Laboratories, Inc.
ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives
Advice regarding the use of the device. HPRA Ref: CRN00FCCQ
Atrium Medical Corporation/Getinge
Advanta VXT and Flixene Vascular Grafts
Advice regarding a device removal. HPRA Ref: CRN00FFD4
Beckman Coulter
DxI 9000 Access Immunoassay Analyzer
Advice regarding the use of the device. HPRA Ref:CRN00FDQN
Beckman Coulter
DxI 9000 Access Immunoassay Analyzer
Advice regarding the use of the device. HPRA Ref:CRN00FDR4
Becton, Dickinson and Company
BD MultitestTM 6-Color TBNK and BD MultitestTM 6-Color TBNK with BD TrucountTM Tube
Advice regarding a device removal. HPRA Ref:CRN00FC05
BioFire Diagnosticss, LLC
BIOFIRE FILMARRAY TORCH Base
Advice regarding the use of the device. HPRA Ref:CRN00FF72
Flexicare Medical Limited
Britepro Solo Single-Use Fiber Optic Laryngoscope
Advice regarding a device removal. HPRA Ref:CRN00FDQ1
GE Healthcare Finland Oy
Centricity High Acuity Anesthesia
Advice regarding a software upgrade. HPRA Ref:CRN00FDDV
GE Healthcare Finland Oy
Carescape multi-parameter patient monitors
Advice regarding the use of the device. HPRA Ref:CRN00FC0P
GE Medical Systems Information Technologies, Inc.
CardioLab, ComboLab
Advice regarding a device modification. HPRA Ref:CRN00FDK8
Hamilton Medical AG
HAMILTON-C6
Advice regarding a software upgrade. HPRA Ref:CRN00FDNH
Integra LifeSciences (Ireland) Limited
Cusa Excel 23kHz Straight Handpiece 1
Advice regarding a device removal. HPRA Ref:CRN00FF11
Integra LifeSciences (Ireland) Limited
Cusa Excel 23kHz Straight Handpiece 2
Advice regarding a device removal. HPRA Ref:CRN00FF11
"Johnson & Johnson International Ethicon LLC"
VICRYL™ & VICRYL™ Plus, PDS™ II & PDS™ II Plus, MONOCRYL™ & MONOCRYL™ Plus Sutures 1
Advice regarding a device removal. HPRA Ref:"CRN00FD0W"
"Johnson & Johnson International Ethicon LLC"
VICRYL™ & VICRYL™ Plus, PDS™ II & PDS™ II Plus, MONOCRYL™ & MONOCRYL™ Plus Sutures 2
Advice regarding a device removal. HPRA Ref:" CRN00FD14"
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
Medtronic
Ascenda™ Intrathecal Catheter
Advice regarding a device modification. HPRA Ref: CRN00FD07
Medtronic Inc.
DBS Clinician Programmer Model A610, Pocket Adaptor for Deep Brain Stimulation: 64001, 64002
Advice regarding the use of the device. HPRA Ref:CRN00FDCD
Medtronic Inc.
High Voltage Capacitor Component (Blackwell and Polaris Devices)
Advice regarding a device removal. HPRA Ref:CRN00F9C7
Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode
Advice regarding a device removal. HPRA Ref:CRN00FCZ3
Philips Medical Systems
PIC iX, PIC iX Expand
Advice regarding a software upgrade. HPRA Ref:CRN00F914
Philips Medical Systems Nederland B.V.
g-MDU connections for MR systems
Advice regarding the use of the device. HPRA Ref:CRN00F9R7
Philips Medical Systems Nederland BV
Philips Hemodynamic System
Advice regarding a software upgrade. HPRA Ref:CRN00FC7Y
Philips Medical Systems Nederland BV
Height Adjustable (HA) FlexTrak Trolley
Advice regarding the use of the device. HPRA Ref:CRN00FCTG
Philips Medizin Systeme Böblingen GmbH
Avalon Ultrasound Transducer
Advice regarding the use of the device. HPRA Ref:CRN00FFK2
Randox Laboratories Ltd
Total Bilirubin Vanadate Oxidation Method
Advice regarding changes/updates made to instructions for use. HPRA Ref:CRN00DW7X
Randox Laboratories Ltd.
Randox HbA1c Calibrator Set
Advice regarding changes/updates made to instructions for use. HPRA Ref:CRN00FDCP
Respironics Inc.
BiPAP A30 Ventilator, BiPAP A40 Ventilator
Advice regarding the use of the device. HPRA Ref:CRN00F7HC
Roche Diabetes Care GmbH
Roche Diabetes Care Platform
Advice regarding a software upgrade. HPRA Ref: CRN00FF69
Roche Diagnostics GmbH
Elecsys Troponin T hs
Advice regarding changes/updates made to instructions for use. HPRA Ref:V53796
Siemens Healthcare Diagnostics Products Ltd
IMMULITE® 2000 Anti-TG Ab
Advice regarding a device removal. HPRA Ref:CRN00F9NY
Stryker Neurovascular
Trevo Retrievers/Microcatheters, FlowGate2, Distal Access Catheter (DAC) and Synchro
Advice regarding a device removal. HPRA Ref:CRN00FF9G
Surgical Holdings
Ganz Osteotome
Advice regarding a device modification. HPRA Ref:CRN00FC9L
The Surgical Company International B.V.
Fluido Trauma set Sterile
Advice regarding a device removal. HPRA Ref:CRN00F946
Thoratec Corporation
HeartMate System Monitor
Advice regarding the use of the device. HPRA Ref:CRN00FCL2
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Date Printed: 06/10/2024