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Summary of Field Safety Notices - February 2015
Notice type:
3rd Party Publications
Date:
03/03/2015
Further Information:
Abbott
ARCHITECT Anti-HBc II
Advice regarding a device removal. HPRA Ref: V23532
Baxter
Peritoneal Dialysis Transfer sets, Titanium adapters, Disconnect caps and Clamshell FSN 1
Peritoneal Dialysis Transfer sets, Titanium adapters, Disconnect caps and Clamshell FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23426
Beckman Coulter
Access 2 / UniCel Dxl Systems
Advice regarding a software upgrade. HPRA Ref: V10169
Biocompatibles UK Limited
Bead Block (Embolic Bead)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23368
Biomet
Mallory Shell
Advice regarding a device removal. HPRA Ref: V23473
Caresono
PadScan HD5
Advice regarding a device removal. HPRA Ref: V23348
Carl Zeiss Ltd.
FORUM VIEWER V.3.1, V.3.2
Advice regarding a software upgrade. HPRA Ref: V23218
Chien Ti Enterprise Co. Limited
Leo, Orion and Comet Scooters
Advice regarding a device modification. HPRA Ref: V23462
Convatec
Unomedical a/s Infusion sets - Comfort™, Comfort™ Short, and Contact™ Detach Infusion Sets- Tubing May Detach From the Connect/Disconnect Location
Advice regarding the use of the device. HPRA Ref: V22547
Cook Medical
Zenith Alpha™ Thoracic Endovascular Graft
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23294
DePuy Synthes
Small Electric Drive
Advice regarding a device removal. HPRA Ref: V22752
Edwards
Edwards Commander Delivery System
Advice regarding the use of the device. HPRA Ref: V23403
Gambro
UltraFilter U9000
Advice regarding the use of the device. HPRA Ref: V22958
GE Healthcare
Proteus XR/a
Advice regarding a device modification. HPRA Ref: V23484
Human
URIC ACID Liquicolor Plus
Advice regarding the use of the device. HPRA Ref: V23515
Mackworth Healthcare
All Mackworth Healthcare Slings fitted with a DOSEC clip
Advice regarding the use of the device. HPRA Ref: V23394
Ortho Clinical Diagnostics
ORTHO Vision Analyser
Advice regarding the use of the device. HPRA Ref: V23435
Philips Healthcare
MultiDiagnost Eleva FD
Advice regarding a software upgrade. HPRA Ref: V23344
Philips Healthcare
Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core 128, Ingenuity Flex and MX8000 Dual v.EXP
Advice regarding the use of the device. HPRA Ref: V23439
Philips Healthcare
Philips IntelliVue Information Centre (PIIC) iX
Advice regarding a software upgrade. HPRa Ref: V22972
Philips Healthcare
Allura Zper R7.2.x
Advice regarding a software upgrade. HPRA Ref: V23543
Randox Laboratories Limited
Liquid Urine Control Level 2 UC5074
Advice regarding a device modification. HPRA Ref: V23454
RMS Limited
Simba Buggy, size 1 and 2
Advice regarding a device modification. HPRA Ref: V23395
Roche Diagnostics
cobas b 221 system
Advice regarding the use of the device. HPRA Ref: V21332
Siemens AG Healthcare Sector
AXIOM Artis or Artis zee systems
Advice regarding a device modification. HPRA Ref: V21056
Siemens Healthcare
Siemens Capillary Caps for RAPIDLyte® Multicap and Multicap®-S Blood Collection Capillaries
Advice regarding the use of the device. HPRA Ref: V23202
Siemens Healthcare
IMMULITE® 2000; IMMULITE® 2000 Xpi GI-MA (CA 19-9)
Advice regarding the use of the device. HPRA Ref: V23438
Siemens Healthcare Diagnostics
Sysmex CS-2000i/CS-2100i/CS-5100
Advice regarding the use of the device. HPRA Ref: V23121
Smith & Nephew
Durolane Injectable Hyaluronic Acid Syringes
Advice regarding a device removal. HPRA Ref: V18857
Smiths Medical
CADD™ Medication Cassette Reservoir
Advice regarding a device removal. HPRA Ref: V23309
Stryker
Triathlon Distal Capture Assembly
Advice regarding a device removal. HPRA Ref: V23527
Teleflex Medical
ADAPTOR,040 HUM,INTL AQUA 540 SW, 540 W/ 040 ADAPTOR AQUAPAK 101 SW and various other products
Advice regarding a device removal. HPRA Ref: V23285
Trilux
TRILUX Operating Lighting System AURINIO L 120 PM std
Advice regarding a device modification. HPRA Ref: V23373
Trilux
TRILUX Examination Light Aurinio L 50 (Ceiling Mounted)
Advice regarding a device modification. HPRA Ref: V23409
UreSil
Thoracic Vent Procedure Tray
Advice regarding the use of the device. HPRA Ref: V23471
WEINMANN Medical Technology
MEDUMAT Transport ventilator (with and without CO2 measurement); software versions 5.x
Advice regarding a software upgrade. HPRA Ref: V23499
ZipLine Medical
Zip® 16 Surgical Skin Closure Devices
Advice regarding a device removal. HPRA Ref: V23422
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Date Printed: 24/04/2024