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Summary of Field Safety Notices - June 2022
Notice type:
3rd Party Publications
Date:
04/07/2022
Further Information:
Abbott
Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kit
Advice regarding the use of the device. HPRA Ref: V47379
Abbott GmbH
ARCHITECT Hemoglobin A1c (A1c) and Alinity c Hemoglobin A1c (HbA1c) Reagent Kit FSN 1
ARCHITECT Hemoglobin A1c (A1c) and Alinity c Hemoglobin A1c (HbA1c) Reagent Kit FSN 2
Advice regarding a device modification. HPRA Ref: V51678
Abbott Sylmar
Merlin and Merlin 2 Patient Care System and Merlin.net Remote Monitoring Application
Advice regarding a software upgrade. HPRA Ref: V51704
Agilent Technologies Singapore Pte Ltd
AriaDx Real-Time PCR System
Advice regarding a software upgrade. HPRA Ref: V51618
Ambu A/S
Ambu VivaSight 2 DLT
Advice regarding a device removal. HPRA Ref: V51511
Arrow International c/o Teleflex Medical
Arrow Central Venous Catheter (CVC) and Percutaneous Sheath Introducer (PSI)
Advice regarding a device removal. HPRA Ref: V51680
Axis-Shield Diagnostics Ltd
Axis-Shield RPR
Advice regarding the use of the device. HPRA Ref: V51761
Bohus BioTech AB
Microvisc, Microvisc Plus, Microvisc Phaco, BBTvis
Advice regarding a device removal. HPRA Ref: V51708
Chromsystems Instruments & Chemicals GmbH
MassCheck AminoAcids, Acylcarnitines Dried Blood
Advice regarding a device modification. HPRA Ref: V51433
Covidien IIc
Palindrome Catheter, Mahurkar Catheter
Advice regarding a device removal. HPRA Ref: V51457
GE healthcare
Centricity Universal Viewer Zero Footprint client
Advice regarding a software upgrade. HPRA Ref: V51811
Integra LifeSciences
Codman® CereLink® ICP Monitor - Distributor FSN
Codman® CereLink® ICP Monitor - Hospital FSN
Advice regarding the use of the device. HPRA Ref: V51816
Maquet Critical Care AB
Servo Ventilator - FSN 1
Servo Ventilator - FSN 2
Advice regarding a software upgrade. HPRA Ref: V51780
Maquet Critical Care AB
Servo-air
Advice regarding the use of the device. HPRA Ref: V51818
Medtronic
Medtronic Valiant Navion™ Thoracic Stent Graft System
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V45767
Medtronic
TruClear™ Hysteroscopic Tissue Removal System Control Unit
Advice regarding a device removal. HPRA Ref: V51461
Medtronic Inc.
Cobalt / Crome ICD
Advice regarding a software upgrade. HPRA Ref: V51792
Philips Medical Systems
M5071A (adult) and M5072A (infant/child) pads for use with HS1/OnSite/Home AEDs - FSN Summary
M5071A (adult) and M5072A (infant/child) pads for use with HS1/OnSite/Home AEDs - FSN
Advice regarding the use of the device. HPRA Ref: V50631
Raffin Medical
Raffin Sets
Advice regarding a device removal. HPRA Ref: V51729
Randox Laboratories Limited
MultiSTAT DoA Urine and Randox MultiSTAT DoA Blood
Advice regarding a device modification. HPRA Ref: V51647
Respironics California, LLC
Philips V680 Ventilator
Advice regarding a software upgrade. HPRA Ref: V51611
SCHILLER MEDICAL
DEFIGARD Touch-7
Advice regarding a software upgrade. HPRA Ref: V51724
Surgical Innovations
YelloPort Elite Universal Seal
Advice regarding a device removal. HPRA Ref: V51598
The Magstim Company Ltd.
Neurosign V4
Advice regarding a device modification. HPRA Ref: V51610
Ventana Medical Systems Inc
VENTANA HE 600 System
Advice regarding a device modification. HPRA Ref: V51640
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Date Printed: 04/12/2023