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Field Safety Notice – August 2018
Notice type:
3rd Party Publications
Date:
04/09/2018
Further Information:
Abbott
Alinity hq Analyzer
Advice regarding a software upgrade. HPRA Ref: V36968
Abbott Laboratories
ARCHITECT c4000 , ARCHITECT c8000 , ARCHITECT c16000 Processing Module
Advice regarding a software upgrade. HPRA Ref: V36542
Bausch& Lomb Inc.
Stellaris Elite Single Port Vitrectomy Cutters
Advice regarding a device removal. HPRA Ref: V36715
Beckman Coulter Inc
UniCel DxH 800 Coulter Cellular Analysis System, UniCel DxH 600 Coulter Cellular Analysis System
Advice regarding a software upgrade. HPRA Ref: V36747
DiaMed GmbH
IH-Com Kit Fullversion and IH-Com Kit For Reader
Advice regarding a software upgrade. HPRA Ref: V36491
Elekta inc.
MOSAIQ
Advice regarding a software upgrade. HPRA Ref: V36659
Etac AS
Molift 2-poing Sling Bar - all sizes
Advice regarding the use of the device. HPRA Ref: V36517
Ethicon Endo-Surgery
5mm ENDOPATH® XCEL™ Trocars with Optiview Technology (Product Codes 2B5LT, 2CB5LT, 2B5ST, 2CB5ST, 2B5XT)
Advice regarding a device removal. HPRA Ref: V35272
Fannin L.I.P
W11326 Staph/Strep Selective Agar Modified, W11320 Fastidious Anaerobic Agar + Nav
Advice regarding a device removal. HPRA Ref: V36893
Fresenius Medical Care AG & Co. KGaA
5008 CorDiax HD-PAED
Advice regarding the use of the device. HPRA Ref: V36310
Implant Direct
Legacy™ Implant Closed-Tray Transfer-Concave Profile 3.5mmD Platform
Advice regarding a device modification. HPRa Ref: V36007
Medcomp
Multiple Medcomp hemodialysis products
Advice regarding a device removal. HPRA Ref: V36548
Medica Medizintechnik GmbH
THERA-Trainer balo / THERA-Trainer verto
Advice regarding a device modification. HPRA Ref: V36701
Medtronic
MiniMed™ remote controller (MMT-500 or MMT-503) FSN 1
MiniMed™ remote controller (MMT-500 or MMT-503) FSN 2
Advice regarding the use of the device. HPRA Ref: V36720
NHG- Nursing Hygiene Group
Steiss Activate Hoists
Advice regarding a device modification. HPRA Ref: V36070
Permobil AB
Permobil M300 PS, C300 PS, C350 PS
Advice regarding a device modification. HPRA Ref: V36819
Randox Laboratories Limited
RX Imola RX4900
Advice regarding a software upgrade. HPRA Ref: V35596
Roche
Elecsys Vitamin D total II
Advice regarding the use of the device. HPRA Ref: V35604
Roche
Cobas e 411 analyser
Advice regarding the use of the device. HPRA Ref: V36902
Roche Diagnostics GmbH
CoaguChek XS PT Test PST, CoaguChek XS PT Test, CoaguChek PT Test FSN 1
CoaguChek XS PT Test PST, CoaguChek XS PT Test, CoaguChek PT Test FSN 2
Advice regarding the use of the device. HPRA Ref: V36870
Sheffmed
Multiple Surgical Instruments, see FSN.
Advice regarding a device removal. HPRA Ref: V36810
Siemens
Biograph Horizon systems running VJ10A, VJ10B, and VJ20A
Advice regarding a software upgrade. HPRA Ref: V35173
Siemens
AXIOM Aristos MX/VX
Advice regarding a device modification. HPRA Ref: V36292
Siemens
Hematek Wright-Giemsa Stain Pak, Hematek Modified Wright Stain Pak
Advice regarding a device removal. HPRA Ref: V36742
Somatex
Transplant – Aspiration Needle / Biopsy Cannula SPI-CUT
Advice regarding a device removal. HPRA Ref: V36738
Stryker
Vizadisc Knee Procedure Tracking Kit, Vizadisc Hip Procedure Tracking Kit.
Advice regarding a device removal. HPRA Ref: V36654
Sysmex
XN series analysers
Advice regarding a software upgrade. HPRA Ref: V36887
Therakos Inc.
THERAKOS™ CELLEX™ Photopheresis System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34584
Ventana Medical Systems Inc / Roche Diagnostice GmbH
FLO-LOK III Dispenser FSN 1
FLO-LOK III Dispenser FSN 2
Advice regarding a device removal. HPRA Ref: V36721
William Cook Europe
Zenith Alpha™ Thoracic Endovascular Graft
Advice regarding the use of the device. HPRA Ref: V36831
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Date Printed: 19/04/2024