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Summary of Field Safety Notices – August 2014
Notice type:
3rd Party Publications
Date:
03/09/2014
Further Information:
AbbVie Inc.
AbbVie NJ Tube
Advice regarding changes/updates made to instructions for use - HPRA Ref: V21558
Aerogen Limited
Aeroneb Pro, Solo, USB and NIVO Nebuliser Systems
Advice regarding a device removal - HPRA Ref: V21791
American Medical Systems
AdVance XP Male Sling System
Advice regarding a device removal - HPRA Ref: V21479
Angiodynamics
UNI*FUSE™ Infusion System with Cooper Wire™
Advice regarding a device removal - HPRA Ref: V21638
Baxter Healthcare
DURA-GUARD, PERI-GUARD, and VASCU-GUARD
Advice regarding the use of the device - HPRA Ref: V21683
Becton Dickinson & Company
BD EpiCenter v6.12A, v6.20A, v6.40A (used in conjunction with MALDI BioTyper)
Advice regarding a device modification - HPRA Ref: V21609
Coris Bioconcept
Rotavirus positive control
Advice regarding a device removal - HPRA Ref: V21773
DePuy Synthes
DePuy Charnley Pin Retractor & Handle Set
Advice regarding a device removal - HPRA Ref: V21827
Dräger Medical GmbH
Babytherm 8000WB, Babytherm 8004, Babytherm 8010
Advice regarding a device modification - HPRA Ref: V21742
Elekta
Monaco
Advice regarding a software upgrade - HPRA Ref: V21602
Elekta
Precise Treatment Table
Advice regarding a device modification - HPRA Ref: V21687
GE Healthcare
Single-width Airway Module E-miniC and Extension Modules N-FC, N-FCREC
Advice regarding a device removal - HPRA Ref: V21477
GE Healthcare
Discovery XR656
Advice regarding a device modification - HPRA Ref: V21707
Gebrüder Martin GmbH & Co. KG
Vaginal Speculum Scherbak with Weight, 400 and 800g
Advice regarding a device removal - HPRA Ref: V21781
Getinge Disinfection AB
Getinge 46-Series Washer-Disinfector
Advice regarding a device modification - HPRA Ref: V21677
Intergra Lifesciences
Integra® Licox® PtO2 Monitors (LCX02-LCX02R
)
Advice regarding a device modification - HPRA Ref: V21716
Intuitive Surgical Inc.
Da Vinci Surgical System
Advice regarding a device modification - HPRA Ref: V21615
Medline International Germany GmbH
Microtek Basin Liners included in Medline Custom Sterile Packs
Advice regarding a device removal - HPRA Ref: V21208
Philips Healthcare
IntelliSpace Portal Software Versions 5 and 6
Advice regarding a software upgrade - HPRA Ref: V21713
Philips Healthcare
Pinnacle Radiation Treatment Planning System
Advice regarding the use of the device - HPRA Ref: V21769
Pro-Lab Diagnostics
Lugols Iodine Solution
Advice regarding a device removal - HPRA Ref: V21710
Siemens AG Healthcare
Symbia T/Intevo Series
Advice regarding a device modification - HPRA Ref: V21577
Siemens AG Healthcare Sector
E.cam
Advice regarding the use of the device - HPRA Ref: V21568
Siemens AG Healthcare Sector
E.cam and Symbia E collimator carts
Advice regarding a device modification - HPRA Ref: V21570
Siemens Healthcare Diagnostics
ADVIA Centaur and ADVIA Centaur XP
Advice regarding the use of the device - HPRA Ref: V21671
Siemens Healthcare Diagnostics
ADVIA Centaur® / ADVIA Centaur® XP
Advice regarding the use of the device - HPRA Ref: V21793
Single Use Surgical
Pulse Lavage System S353
Advice regarding a device modification - HPRA Ref: V21685
St. Jude Medical CRMD
Ellipse™ VR/DR
Advice regarding a device removal - HPRA Ref: V21711
Sunrise Medical Limited
Sunlift Range of Hoists, 175E and 150E
Advice regarding the use of the device - HPRA Ref: V21686
Vapotherm
Vapotherm Precision Flow, Disposable Patient Circuit
Advice regarding a device removal - HPRA Ref: V21770
Varian Medical Systems
4D Integrated Treatment Console
Advice regarding the use of the device - HPRA Ref: V21708
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Date Printed: 20/04/2024