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Summary of Field Safety Notices - August 2023
Notice type:
3rd Party Publications
Date:
04/09/2023
Further Information:
Acutronic Medical Systems AG
Acutronic Medical Systems AG TV1 Ventilator
Advice regarding a device removal, HPRA Ref: CRN00DS7Z
Arthrex INC
Knee Scorpion™
Advice regarding the use of the device, HPRA Ref: CRN00DRVG
B.Braun
Infusomat Space – Upstream Occlusion Sensor
Advice regarding a device removal, HPRA Ref: CRN00DSMQ
Baxter Healthcare SA
EVO IQ Large Volumetric Pump
Advice regarding the use of the device, HPRA Ref: CRN00DRHJ
Biocomposites Ltd.
GeneX DS 2.5cc and 5cc
Advice regarding changes/updates made to instructions for use, HPRA Ref: CRN00DS7X
BioMérieux
EBV R-GENE and BK Virus R-GENE
Advice regarding the use of the device, HPRA Ref: CRN00DR2L
CamDiab Ltd
mylife CamAPS FX Users
mylife CamAPS FX HCPs
Advice regarding a software upgrade, HPRA Ref: CRN00DRSN
Covidien Ilc
McGRATH™ MAC 2 Disposable Laryngoscope Blades
Advice regarding a device removal, HPRA Ref: CRN00DRSJ
Datascope Corp.
Cardiosave Intra-Aortic Balloon Pumps
Advice regarding the use of the device, HPRA Ref: CRN00DRJZ, CRN00DS55, CRN00DS5L & CRN00DS5N
Datascope Corp.
Cardiosave Intra-Aortic Balloon Pumps
Advice regarding the use of the device, HPRA Ref: CRN00DS52 & CRN00DS5G
Datascope Corp.
Cardiosave Intra-Aortic Balloon Pumps
Advice regarding the use of the device, HPRA Ref: V54445
Draeger Medical Systems, Inc.
Babyroo TN300 Radiant Warmer
Advice regarding the use of the device, HPRA Ref: CRN00DRJN
Ethicon LLC & Johnson & Johnson International
PDS™ II (polydioxanone) Suture, PDS™ Plus Antibacterial (polydioxanone) Suture
Advice regarding a device removal, HPRA Ref: CRN00DR5C
Getinge Disinfection AB
APERLAN PY AGENT A, APERLAN PY AGENT B
Advice regarding a device removal, HPRA Ref: CRN00DQD3
Hamilton Medical AG
Hamilton-C1, Hamilton-T1, Hamilton-MR1
Advice regarding a device modification, HPRA Ref: CRN00DR4L
Hamilton Medical AG
Hamilton Medical In2Flow Nasal cannulas
Advice regarding the use of the device, HPRA Ref: CRN00DSXS
Henke-Sass, Wolf GmbH
Henke-Ject FSN 1
Henke-Ject FSN 2
Advice regarding a device removal, HPRA Ref: CRN00DR28
ICU Medical
Medfusion™ Model 3500 and Model 4000 Syringe Infusion Pumps
Advice regarding the use of the device, HPRA Ref: CRN00DS8N
Instrumentation Laboratory Co.
HemosIL Liquid Anti-Xa
Advice regarding changes/updates made to instructions for use, HPRA Ref: V54469
Invivoscribe, Inc.
LymphoTrack®Dx IGH - MiSeq® FSN 1
LymphoTrack®Dx IGH - MiSeq® FSN 2
Advice regarding a device removal, HPRA Ref: CRN00DS8T
Maquet Cardiopulmonary GmbH
Custom Tubing Packs
Advice regarding a device removal, HPRA Ref: CRN00DS36
Maquet Cardiopulmonary GmbH
PLS Set; HLS Set Advanced5.0; HLS Set Advanced 7.0
PLS Set; HLS Set Advanced5.0; HLS Set Advanced 7.0 Annex
Advice regarding the use of the device, HPRA Ref: V52053
Maquet GmbH
MEERA operating table with autodrive
Advice regarding a software upgrade, HPRA Ref: CRN00DRZ9
Medline International France SAS
Magnetic Instrument Drape
Advice regarding a device removal, HPRA Ref: CRN00DS5V
Meyra GmbH
iCHAIR SKY 1.62
Advice regarding the use of the device, HPRA Ref: CRN00DR4Q
NOUVAG AG
Dispenser DP30
Advice regarding changes/updates made to instructions for use, HPRA Ref: CRN00DR4F
Olympus Medical Systems Corporation
BF-Series bronchoscopes, LF-Series tracheal intubation scopes, MAF-Series airway mobilescopes
Advice regarding the use of the device, HPRA Ref: CRN00DRDG
PEROUSE MEDICAL
POLYFILM
Advice regarding a device removal, HPRA Ref: CRN00DRWG
Philips
Patient Information Center (PIC iX) Release 4.x
Advice regarding a software upgrade, HPRA Ref: CRN00DSKH
Philips Medical Systems Nederland BV
Allura Xper, Allura Centron, Azurion, MultiDiagnost-Eleva Systems
Advice regarding the use of the device, HPRA Ref: CRN00DRQP
Philips Medical Systems Nederland BV
Philips Allura Xper, Azurion and MultiDiagnost-Eleva FSN 1
Philips Allura Xper, Azurion and MultiDiagnost-Eleva FSN 2
Advice regarding the use of the device, HPRA Ref: CRN00DS7T
Plasma Biotics
Connection sets ref. 301027 (model PP EB-J10) & ref. 301027-1 (model PP EB-J10/A) for PlasmaTYPHOON products
Advice regarding the use of the device, HPRA Ref: CRN00DQ2D
Randox Laboratories Ltd
Liquid Assayed Chemistry Control Premium Plus Level 3
Advice regarding a device modification, HPRA Ref: CRN00DRDW
Remote Diagnostic Technologies Ltd.
Tempus Pro
Advice regarding a software upgrade, HPRA Ref: CRN00DST2
Siemens Healthineers
Headphone artifacts
Advice regarding a device modification, HPRA Ref:CRN00DSXN
St. Jude Medical
Trifecta Valve and Trifecta Valve with Glide Technology
Advice regarding a device removal, HPRA Ref: V54285
St. Jude Medical Cardiac Rhythm Management Division
Gallant ICDs and CRT-Ds
Advice regarding a software upgrade, HPRA Ref: CRN00DRTT
Thommen Medical AG
SPI®ELEMENT impl. RC INICELL®
Advice regarding a device removal, HPRA Ref: CRN00DSLV
Thoratec Corporation
HeartMate Touch Communication System
Advice regarding the use of the device, HPRA Ref: CRN00DR64
Thoratec Corporation
Apical Coring Knife
Advice regarding the use of the device, HPRA Ref: CRN00DSHM
W.O.M. World of Medicine GmbH
Aquilex Fluid Control System
Advice regarding a software upgrade, HPRA Ref: CRN00DQ9M
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Date Printed: 02/05/2024