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Summary of Field Safety Notices - March 2024
Notice type:
3rd Party Publications
Date:
02/04/2024
Further Information:
Summary of Field Safety Notices- March 2024
Abbott Molecular, Inc.
Alinity m System
Advice regarding the use of the device HPRA Ref:CRN00F71G
Abiomed Inc.
Impella CP, Impella 5.5, Impella RP, Impella 5.0
Advice regarding the use of the device HPRA Ref: CRN00F4GQ
Advena Limited
Vizulize Irritated Eye Mist & Pollenase Allergy Eye Mist
Advice regarding a device removal HPRA Ref:CRN00F4ZK
Agilent Technologies Inc.
Dako CoverStainer and Dako CoverStainer Certified Pre-Owned
Advice regarding the use of the device HPRA Ref:CRN00F74X
Allurion
Allurion Device / Elipse Gastric Balloon System
Advice regarding the use of the device HPRA Ref:CRN00F4V7
Andratec GmbH
AltoSa-XL-Gemini Balloon Catheter
Advice regarding a device removal HPRA Ref:CRN00F700
Boston Scientific Corporation
EXPO™ 5F Angiographic Catheters
Advice regarding a device removal HPRA Ref: CRN00F6DD
Convatec Ltd
CarboFlex®
Advice regarding a device removal HPRA Ref:CRN00F57J
Covidien Auto Suture™ Structural Balloon Trocar & Auto Suture™ Blunt Tip Trocar
Covidien IIc
Advice regarding the use of the device HPRA Ref:CRN00F3ZD
Covidien llc
Hugo™ RAS Surgeon Console
Advice regarding the use of the device HPRA Ref:CRN00F708
Covidien llc
Hugo™ RAS Tower
Advice regarding the use of the device HPRA Ref: CRN00F70C
Drägerwerk AG & Co. KGaA
Perseus A500
Advice regarding the use of the device HPRA Ref:CRN00F5DV
Epic Systems Corporation
Regulated Decision Support Framework
Advice regarding a software upgrade HPRA Ref:CRN00F5HS
EQUASHIELD Medical Ltd
EQUASHIELD® Closed System Transfer Device, Spike Tubing, Ref. SA-1E
Advice regarding a device modification HPRA Ref:CRN00F6ZV
Gyrus ACMI, Inc. (Olympus Surgical Technologies America)
Soltive™ SuperPulsed Laser System
Advice regarding a device removal HPRA Ref:CRN00F4Y3
Intuitive Surgical, Inc.
SureForm45/60, Cannula Seal, Arm Drape, Obturator
Advice regarding a device removal HPRA Ref:CRN00F5MT
Luminex, A DiaSorin Company
NxTAG Respiratory Pathogen Panel & NxTAG Respiratory Pathogen Panel + SARS-CoV-2
Advice regarding the use of the device HPRA Ref:CRN00F3PF
Luminex, A DiaSorin Company
NxTAG Respiratory Pathogen Panel & NxTAG Respiratory Pathogen Panel + SARS-CoV-2
Advice regarding the use of the device HPRA Ref:CRN00F79S
Maquet Cardiopulmonary GmbH
HLS Set
Advice regarding the use of the device HPRA Ref:CRN00F0WZ
Maquet Cardiopulmonary GmbH
Cardiohelp-i
Advice regarding a device modification HPRA Ref:CRN00F7DM
Maquet SAS’ OR Light Systems
MAQUET SAS
Advice regarding changes/updates made to instructions for use HPRA Ref:CRN00F25V
Medartis AG
TriLock Distal Radius Plates
Advice regarding a device removal HPRA Ref:CRN00F6ZQ
Medartis GmbH
1.2 K-Draht, Lanzette, 150mm
Advice regarding a device removal HPRA Ref:CRN00F5YR
Medtronic Inc.
Cannulae
Advice regarding a device removal HPRA Ref:CRN00F79V
Medtronic Limited
Palindrome Precision H Chronic Catheter Kit 23 cm/40 cm
Advice regarding a device removal HPRA Ref:CRN00F5KQ
Medtronic Navigation, Inc.
SOFTWARE APP 9735762 STEALTH S8 APPLICATION
Advice regarding a software upgrade HPRA Ref:CRN00DVMQ
NRT X-Ray A/S
Celex, Intelli-C
Advice regarding a device modification HPRA Ref:CRN00F70W
Olympus
HIGH FLOW INSUFFLATION UNIT
Advice regarding the use of the device HPRA Ref:CRN00F6Q5
Philips Respironics, Inc.
Trilogy Evo,Trilogy Evo O2,Trilogy EV300
Advice regarding the use of the device HPRA Ref:CRN00F630
Randox Laboratories Ltd
Liquid Protein Calibrators
Advice regarding a device modification HPRA Ref: CRN00F4T4
Randox Laboratories Ltd
Calibration Serum Level 3
Advice regarding the use of the device HPRA Ref: CRN00F5QX
Randox Laboratories Ltd.
Cystatin C Calibrator (CYSC CAL)
Advice regarding changes/updates made to instructions for use HPRA Ref:CRN00F45K
Siemens Healthcare Diagnostics Inc
Atellica CH Iron3
Advice regarding the use of the device HPRA Ref:CRN00F642
Smiths Medical
CADD-Solis™ Ambulatory Infusion Pumps
Advice regarding a software upgrade HPRA Ref:CRN00F76T
SYNOVIS LIFE TECHNOLOGIES, INC (SUBSIDIARY OF BAXTER INTERNATIONAL INC)
PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch
Advice regarding changes/updates made to instructions for use HPRA Ref:CRN00F53X
SYNOVIS LIFE TECHNOLOGIES, INC (SUBSIDIARY OF BAXTER INTERNATIONAL INC)
Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch
Advice regarding changes/updates made to instructions for use HPRA Ref:CRN00F5GH
Synthes GmbH
Trochanteric Fixation Nail - Advanced; 2.7mm VA LCP Clavicle Plates System; OPAL Intervertebral Cage
Advice regarding a device removal HPRA Ref:CRN00F2W7
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Date Printed: 30/04/2024