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Summary of Field Safety Notices - December 2014
Notice type:
3rd Party Publications
Date:
07/01/2015
Further Information:
Abbott Medical Optics
Healon EndoCoat Opthalmic Viscosurgical Device & Healon Duet Dual Pack
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22523
Aircraft Medical
McGRATH® MAC2 Video Laryngoscope Blade
Advice regarding a device removal. HPRA Ref: V22626
Alere
Alere Determine HIV-1/2 Ag/Ab Combo
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22498
Alere
Alere™ INRatio® PT/INR Monitor System - FSN 1
Alere™ INRatio® PT/INR Monitor System - FSN 2
Advice regarding the use of the device. HPRA Ref: V22821
American Medical Systems Inc.
AMS 700 Accessory Kit - Lightning Bolt Keith Needles
Advice regarding a device removal. HPRA Ref: V22533
Bausch & Lomb Inc.
Stellaris PC Vision Enhancement System with Laser
Advice regarding a software upgrade. HPRA Ref: V22585
Baxter
COLLEAGUE Pump vP1.7.
Advice regarding the use of the device. HPRA Ref: V22824
Beckman Coulter
Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, Lipase
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22800
bioMerieux
Toxo ISAGA IgA
Advice regarding a device removal. HPRA Ref: V22787
Biosense Webster
Thermocool Smarttouch SF Catheter Family
Advice regarding a device removal. HPRA Ref: V22616
Brainlab
iPlan RT / iPlan RT Dose
Advice regarding the use of the device. HPRA Ref: V22738
Breas
Breas Vivo 50 Home Care Ventilator
Advice regarding a device modification. HPRA Ref: V22614
Cook Medical
Günther Tulip® Vena Cava Filter Set Cook Celect® Vena Cava Filter Set Cook Celect® Platinum Vena Cava Filter Set
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22675
Covidien LLC
Puritan Bennett 980 Series Ventilator System - FSN 1
Puritan Bennett 980 Series Ventilator System - FSN 2
Advice regarding a device modification. HPRA Ref: V22228
Covidien LLC
Puritan Bennett 980 Series Ventilator System
Advice regarding a software upgrade. HPRA Ref: V22229
Covidien LLC
Trellis 8 Peripheral Infusion System
Advice regarding a device removal. HPRA Ref: V22852
DePuy Synthes
Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible
Advice regarding a device removal. HPRA Ref: V22912
Etac Supply Center AB
Cross, Cross XL, Cross 5 Wheelchairs
Advice regarding a device modification. HPRA Ref: V22554
Fluoron GmbH
EasyGas
Advice regarding a device removal. HPRA Ref: V22864
GE Healthcare
Millennium VG, Millennium VG and Hawkeye, Discovery VH,and other devices
Advice regarding the use of the device. HPRA Ref: V22465
Halyard Health
KimVent Subglottic Suctioning Endotracheal Tubes
Advice regarding a device removal. HPRA Ref: V22694
iMDsoft
MetaVision Suite, Clinical Information System ver. 5.4x
Advice regarding a software upgrade. HPRA Ref: V22618
Instrumentation Laboratory
HemosIL PT Fibrinogen HS Plus
Advice regarding the use of the device. HPRA Ref: V22690
Integra LifeSciences Corporation
CEM™ Nosecones for use with CUSA® Excel/Excel+ Ultrasonic Aspirator
Advice regarding the use of the device. HPRA Ref: V19593
Intuitive Surgical Inc.
da Vinci Standard™ Surgical System, da Vinci S™ Surgical System, da Vinci Si™ Surgical System, da Vinci Si-e™ Surgical System.
Advice regarding the use of the device. HPRA Ref: V22684
Maquet
PowerLED & HLED, STANDOP VOLISTA, XTEN, HLX3000
Advice regarding the use of the device. HPRA Ref: V22878
Maquet Cardiopulmonary AG
QUADROX-iD Adult/Small Adult; HLS Set Advanced; PLS Set
Advice regarding the use of the device. HPRA Ref: V22911
Medtronic
MiniMed SilhouetteTM and Sure-TTM infusion sets
Advice regarding the use of the device. HPRA Ref: V22478
NxStage Medical
SAK Dialysate Concentrate
Advice regarding a device removal. HPRA Ref: V20962
Oculentis
Lentis HydroSmart foldable Intraocular lenses
Advice regarding a device removal. HPRA Ref: V22747
Owen Mumford Ltd
Autopen Classic, Autopen 24, Densupen and Autopen 3ml for Teriparatide
Advice regarding a device removal. HPRA Ref: V22838
Philips Healthcare
Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex
Advice regarding a device modification. HPRA Ref: V22889
Roche Diagnostics
Cobas b 221
Advice regarding the use of the device. HPRA Ref: V21874
Roche Diagnostics
cobas KRAS Mutation Kit
Advice regarding a device removal. HPRA Ref: V22910
Siemens
Syngo Plaza
Advice regarding the use of the device. HPRA Ref: V22555
St. Jude Medical
All models of RF enabled St. Jude Medical Ellipse™ and other devices
Advice regarding a software upgrade. HPRA Ref: V22903
Stryker Instruments
Neptune Waste Management System
Advice regarding a device modification. HPRA Ref: V22751
Teleflex Medical
Bronchial Double Lumen Tube Set (LEFT), STERILE; and other devices
Advice regarding a device removal. HPRA Ref: V22609
Teleflex Medical
BOSS SYSTEMS Soft Flex, ICOR FH with Soft Flex and other devices - FSN 1
BOSS SYSTEMS Soft Flex, ICOR FH with Soft Flex and other devices - FSN 2
Advice regarding a device removal. HPRA Ref: V22313
Trinity Biotech
Captia Syphilis IgM Capture
Advice regarding a device removal. HPRA Ref: V22654
Trinity Biotech
Stop Solution 916401
Advice regarding the use of the device. HPRA Ref: V22781
Urotech GmbH
Guide Wire Semislip UAS-35150-S
Advice regarding a device removal. HPRA Ref: V22663
Zimmer
Trilogy Bone Screws – 6.5mm X 35mm & 6.5mm X 25mm
Advice regarding a device removal. HPRA Ref: V22820
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Date Printed: 02/07/2022