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Summary of Field Safety Notices - October 2018
Notice type:
3rd Party Publications
Date:
01/11/2018
Product name or type:
Summary of Field Safety Notices
Further Information:
Abbott
ARCHITECT i System, Alinity i System
Advice regarding a device removal. HPRA Ref: V37475
Abbott
Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module FSN 1
Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module FSN 2
Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module Attachment
Advice regarding a software upgrade. HPRA Ref: V37626
Abbott Ireland Diagnostics Division
ARCHITECT i1000SR Free T3 & Total T3 Reagent Kits
Advice regarding the use of the device. HPRA Ref: V37571
Abbott Ireland Diagnostics Division
ARCHITECT i2000/i2000SR Free T3 & Total T3 Reagent Kits
Advice regarding the use of the device. HPRA Ref: V37572
Abbott Ireland Diagnostics Division
Alinity i Free T3 & Total T3 Reagent Kits
Advice regarding the use of the device. HPRA Ref: V37573
Alba Bioscience Limited
ALBAclone Anti-Leb
Advice regarding a device removal. HPRA Ref: V37474
Alba Bioscience Limited
ALBAcyte® Reagent Red Blood Cells Expanded Rh Negative Antibody Screen
Advice regarding a device modification. HPRA Ref: V37647
Biomerieux
NUCLISENS® Lysis Buffer
Advice regarding a device removal. HPRA Ref: V37575
Biomerieux
VITEK® 2 AST-ST01, ST02, ST03
Advice regarding a device modification. HPRA Ref: V37739
Bio-Rad
Pastorex Meningitis
Advice regarding the use of the device. HPRA Ref: V37172
Bridgemaster Medical Limited
BridgeMaster medicalFetal Scalp Blood SamplingKits
Advice regarding the use of the device. HPRA Ref: V37490
Clearstream (BD)
LifeStream Stent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37452
ConvaTec Limited
Suction Catheters, Gastro-enteral Tubes, Intermittent Urology Catheters and sterile Urine Drainage Bags
Advice regarding a device removal. HPRA Ref: V36438
Ekamed GmbH & Co. KG
Ekamove 30° Seitenlagerungssystem
Advice regarding a software upgrade. HPRA Ref: V37551
Endologix International Holdings B.V.
Nellix EndoVascular Aneurysm Sealing System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37610
ESAOTE SPA
MyLab Seven, MyLab Six Crystaline, MyLab Six, MyLab Alpha, MyLab Gamma, MyLabClass C, MyLab Eight, MyLab60, MyLab65, MyLab70, MyLab75, MyLab70 X Vision, MyLab70 XV-L
Advice regarding a software upgrade. HPRA Ref: V36669
ESAOTE SPA
MyLab Alpha, MyLab Seven, MyLab Six Crystaline, MyLab Six, MyLab Gamma
Advice regarding a software upgrade. HPRA Ref: V36670
Fannin LIP
Brazier’s CCEY Agar
Advice regarding the use of the device. HPRA Ref: V37704
Fannin Ltd.
CHROMagar Candida, CHROMagar msuperCARBA
Advice regarding a device removal. HPRA Ref: V37653
GE Healthcare
Dash 3000/4000/5000, Solar 8000M/i, and Solar 9500 patient monitors
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37752
GE Healthcare
B20/B20i/B40/B40i (Bx0), and B105/B125 (B1x5) patient monitors
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37848
Jumper Medical Equipment Co. Ltd.
AngelSounds JPD-100S4 Fetal Doppler
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36759
Magstim
Neurosign V4 Trolley, Neurosign V4 Pre-Amplifier, Neurosign V4 Stimulator Pod & Neurosign V4 Mute Sensor
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37764
Maquet
Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump FSN 1
Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Addendum
Advice regarding the use of the device. HPRA Ref: V37410
Medtronic Ireland Limited
Parietex™ Composite Parastomal Mesh 15cm and 20cm
Advice regarding a device removal. HPRA Ref: V37593
Medtronic Limited
MiniMed™ 640G Insulin Pump
Advice regarding the use of the device. HPRA Ref: V37492
Medtronic Limited
O-arm O2 Imaging System
Advice regarding a software upgrade. HPRA Ref: V37599
Medtronic Navigation, Inc.
O-arm® 1000 Surgical Imaging System (2nd edition)
Advice regarding a software upgrade. HPRA Ref: V37359
Orthofix Srl
Drill Bits
Advice regarding a device removal. HPRA Ref: V37406
Randox Laboratories Ltd
RX Monaco
Advice regarding a software upgrade. HPRA Ref: V37605
Sakura Finetek Europe BV.
Tissue-Tek® AutoSection
Advice regarding a device modification. HPRA Ref: V36588
Siemens
Hematek Wright-Giemsa Stain Pak, Hematek Modified Wright Stain Pak, ADVIA Autoslide Wright-Giemsa Stain, ADVIA Autoslide Modified Wright’s Stain
Advice regarding a device removal. HPRA Ref: V36742
Siemens
RAPIDPoint® 500 Blood Gas Systems
Advice regarding a software upgrade. HPRA Ref: V37459
Siemens Healthcare GmbH
ARTIS Q and ARTIS pheno
Advice regarding a device modification. HPRA Ref: V36627
Siemens Medical Solutions USA, Inc.
Biograph Horizon and Biograph mCT
Advice regarding the use of the device. HPRA Ref: V37560
Smiths Medical
Bivona® Inner Cannula Tracheostomy Tube
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24010
Stryker
LFIT Anatomic CoCr V40 Femoral Heads
Advice regarding a device removal. HPRA Ref: V29355
TP Orthodontics Europe
Generation 1 Jasper Vektor
Advice regarding a device removal. HPRA Ref: V37567
TriVascular Inc, a wholly owned subsidiary of Endologix Inc.
Ovation Abdominal Stent Graft System Platform
Advice regarding the use of the device. HPRA Ref: V36839
Waldmann
UV Therapy System UV 7001
Advice regarding the use of the device. HPRA Ref: V37777
Xiros Ltd
MPFL System Implant
Advice regarding a device removal. HPRA Ref: V37713
Zeiss
Cell Observer SD, DirectFRAP, Laser TIRF
Advice regarding a device modification. HPRA Ref: V37355
Zimmer Biomet
StageOne Hip Cement Spacer Mold
Advice regarding a device removal. HPRA Ref: V37524
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Date Printed: 26/04/2024