My HPRA: Register

Summary of Field Safety Notices - February 2022

Notice type: 3rd Party Publications

Date: 02/03/2022

     

Further Information:
Abbott GmbH
Alinity s System - FSN
Alinity s System - Attachment A
Advice regarding the use of the device. HPRA Ref: V50397


Abbott GmbH
Integrated Reaction Unit (IRU) for the Alinity m system, LN 08N53-002
Advice regarding a device removal. HPRA Ref: V50465


Advanced Medical Solutions Ltd
LiquiBandFIX8® Open Hernia Mesh Fixation Device
Advice regarding a device removal. HPRA Ref: V50420


B.Braun Melsungen AG
Infusomat® Space Line (Transfusion)
Advice regarding a device removal. HPRA Ref: V50415


Bbraun
Spacecom Battery pack SP with wifi, Data Module Compactplus 
Advice regarding a software upgrade. HPRA Ref: V50448


bioMérieux SA
VIDAS® CMV IgM
Advice regarding a device removal. HPRA Ref: V50424


Boston Scientific Corporation
SpaceOAR and SpaceOAR Vue Systems
Advice regarding the use of the device. HPRA Ref: V50468


Brainlab AG
ExacTrac Dynamic
Advice regarding a software upgrade. HPRA Ref: V50548


Breas Medical AB
Ventilator Trolley (Ref 007384) - FSN
Ventilator Trolley (Ref 007384) - Customer Letter
Advice regarding a device modification. HPRA Ref: V50344


CooperVision Manufacturing Ltd 
HyCare Contact Lens Solution. FSN 1
HyCare Contact Lens Solution. FSN 2
HyCare Contact Lens Solution. FSN 3 
Advice regarding a device removal. HPRA Ref: V50423


Drägerwerk AG & Co KGaA
Evita V300; Evita V500; Babylog VN500
Advice regarding the use of the device. HPRA Ref: V50360


GE Healthcare
OEC Elite & OEC 3D
Advice regarding a device modification. HPRA Ref: V50359


GE Medical Systems
GE Healthcare MRI systems
Advice regarding the use of the device. HPRA Ref: V50367


Getinge 
Getinge ED Flow AER and Getinge ED Flow SD AER
Advice regarding a device modification. HPRA Ref: V50349

  
Illumina, Inc.
NextSeq 550Dx Instrument
Advice regarding the use of the device. HPRA Ref: V50530


Immunotech S.A.S.
Access hsTnI Reagent (High Sensitivity Troponin I)
Advice regarding the use of the device. HPRA Ref: V50557


Malvern Medical Developments Ltd 
Oracol+ Saliva Collection Device
Advice regarding a device removal. HPRA Ref: V50302


Maquet Critical Care AB
Servo-u and Servo-n ventilator systems
Advice regarding a device modification. HPRA Ref: V50435

  
Medtronic
MiniMed 640G Insulin Pump, MiniMed 670G Insulin Pump, MiniMed 720G Insulin Pump, MiniMed 740G Insulin Pump, MiniMed 770G Insulin Pump, MiniMed 780G Insulin Pump - FSN 1
MiniMed 640G Insulin Pump, MiniMed 670G Insulin Pump, MiniMed 720G Insulin Pump, MiniMed 740G Insulin Pump, MiniMed 770G Insulin Pump, MiniMed 780G Insulin Pump - FSN 2
Advice regarding the use of the device. HPRA Ref: V50313


Medtronic
Percept PC BrainSense
Advice regarding the use of the device. HPRA Ref: V47660


Ossur hf
Resolve Halo
Advice regarding the use of the device. HPRA Ref: V50338


Philips Goldway (Shenzhen) Industrial Inc.
Philips HeartStart Intrepid Monitor/Defibrillator
Advice regarding the use of the device. HPRA Ref: V50444


Philips Medical Systems
Oesophageal/Rectal/Skin Temperature Probes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V50402


Siemens Healthcare Diagnostics Inc.
Atellica CH Lithium_2 (LITH_2), Atellica CH Enzymatic Hemoglobin A1c (A1c_E), Atellica CH Calcium_2 (CA_2), Atellica CH Fructosamine (Fruc) Glycosylated hemoglobin assay
Advice regarding the use of the device. HPRA Ref: V50389


Siemens Healthcare Diagnostics Inc.
Ysio
Advice regarding a software upgrade. HPRA Ref: V50463


Siemens Healthcare Diagnostics Inc.
IMMULITE® 2000, IMMULITE® 2000 XPi
Advice regarding the use of the device. HPRA Ref: V50547


Siemens Healthcare GmbH
ARTIS icono / pheno
Advice regarding a software upgrade. HPRA Ref: V50467


Siemens Healthcare GmbH
syngo Application Software
Advice regarding a software upgrade. HPRA Ref: V50522


Siemens Healthineers
Atellica® UAS 800 Urine Sediment Analyzer, Atellica® 1500 Automated Urinalysis System
Advice regarding the use of the device. HPRA Ref: V50470


Siemens Medical Solutions USA
ACUSON Juniper ultrasound systems with software version Juniper 1.0
Advice regarding a software upgrade. HPRA Ref: V50365


Smiths Medical ASD, Inc.
Level 1 FastFlow Fluid warming Systems, Normoflo Fluid Warming Systems and  Irrigation Sets, and Level 1 Disposable Products 
Advice regarding the use of the device. HPRA Ref: V47220


Thermo Fisher Scientific Inc.
Infinity™ Ammonia Liquid Stable Reagent & Infinity™ Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers - FSN 1
Infinity™ Ammonia Liquid Stable Reagent & Infinity™ Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers - FSN 2
Advice regarding the use of the device. HPRA Ref: V48119


Wagner Klinikbedarf
MIC Gastrostomy Tub Care Kit 16
Advice regarding the use of the device. HPRA Ref: V50382

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