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Summary of Field Safety Notices - March 2015
Notice type:
3rd Party Publications
Date:
02/04/2015
Further Information:
AcuFocus Inc
KAMRA Corneal Inlay
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23827
Alcon Laboratories
ACRYSOF® CACHET™ Phakic Lens
Advice regarding a device removal. HPRA Ref: V22058
Aspen Medical
Bi-Manual Irrigating / Aspirating Handpieces
Advice regarding a device removal. HPRA Ref: V23402
Bard Limited
Bard® ConQuest PTA Balloon Dilatation Catheter
Advice regarding a device removal. HPRA Ref: V23783
Biomerieux
AST-P635 Test Kit 20 Cards / VITEK 2
Advice regarding the use of the device. HPRA Ref: V23560
Candela Corporation
Gentlelase Pro
Advice regarding a software upgrade. HPRA Ref: V23549
Codman Neuro
Codman CERTAS Therapy Management System
Advice regarding a device removal. HPRA Ref: V23569
Covidien LLC
Puritan Bennett 980 Ventilator
Advice regarding a software upgrade. HPRA Ref: V22988
Dako
Dako Autostainer
Advice regarding the use of the device. HPRA Ref: V23704
DePuy Synthes
Inserter f/TEN
Advice regarding a device removal. HPRA Ref: V23550
DePuy Synthes
LCS COMPLETE RPS Knee System
Advice regarding the use of the device. HPRA Ref: V23613
DePuy Synthes
Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative Systems & Pedicle Awls
Advice regarding the use of the device. HPRA Ref: V23624
Ethicon
Omrix Pressure Regulator
Advice regarding a device removal. HPRA Ref: V23820
Fisher & Paykel
IW900-series Infant Warmers
Advice regarding a device modification. HPRA Ref: V22499
Flexicare
Flexicare Expandable Catheter Mount in Breathing Systems
Advice regarding a device removal. HPRA Ref: V22613
Flexicare
30mm Corrugated Tube in Ventiflow Breathing Circuits
Advice regarding a device removal. HPRA Ref: V23830
Fresenius MedicalCare
FX CorDiax dialysers - hypersensitivity and hypersensitivity-like reactions
Advice regarding the use of the device. HPRA Ref: V23625
Instrumentation Laboratory
IH-1000
Advice regarding a software upgrade. HPRA Ref: V22501
Intuitive Surgical
da Vinci surgical system drapes
Advice regarding a device removal. HPRA Ref: V23812
Invacare
Invacare® Leo®, Orion® & Comet® Scooters
Advice regarding the use of the device. HPRA Ref: V23462
Medtronic
Dual Chamber Temporary Pacemaker
Advice regarding a device modification. HPRA Ref: V23711
Medtronic
Trellis™ 8 Peripheral Infusion Systems
Advice regarding the use of the device. HPRA Ref: V23733
Ortho-Clinical Diagnostics
ORTHO VISION™ Analyzer
Advice regarding a software upgrade. HPRA Ref: V23662
Ortho-Clinical Diagnostics
VITROS 5,1FS Chemistry System
Advice regarding a software upgrade. HPRA Ref: V23710
Philips Healthcare
Philips HeartStart MRx Monitor/Defibrillator
Advice regarding a software upgrade. HPRA Ref: V22689
Philips Healthcare (Suzhou) Co. Limited
Philips MX 16-slice Computed tomorgraphy x-ray system V1.1.3_V1.1.4.21425
Advice regarding a software upgrade. HPRA Ref: V22343
Philips Medical Systems
ADAC Vertex Plus, CARDIO and Solus; ADAC V60; ADAC C60
Advice regarding a device modification. HPRA Ref: V23870
Radiometer
AQT90 FLEX Analyser
Advice regarding a software upgrade. HPRA Ref: V23748
Roche
HCYS – Homocysteine Enzymatic Assay
Advice regarding the use of the device. HPRA Ref: V23657
Siemens Healthcare - Radiation Oncology
Digital Linear Accelerators of type PRIMUS™, ONCOR™ and ARTISTE™ - 550 TxT™ Treatment Table
Advice regarding a software upgrade. HPRA Ref: V23747
Siemens Healthcare Diagnostics
IMMULITE 2000/IMMULITE 2000 Xpi
Advice regarding the use of the device. HPRA Ref: V23616
Smith & Nephew Orthopaedics
BIRMINGHAM HIP™ Modular Head
Advice regarding the use of the device. HPRA Ref: V23705
Synthes GmbH
Multi-Loc screw 48mm
Advice regarding a device removal. HPRA Ref: V23112
Terumo Europe NV
Terumo Two-Parts Syringe
Advice regarding a device removal. HPRA Ref: V23650
TRUMPF Medizin Systeme GmbH + Co. KG
TITAN operating table (remote controls)
Advice regarding a device modification. HPRA Ref: V22508
UreSil LLC
Thoracic Vent Procedure Tray
Advice regarding a device removal. HPRA Ref: V23471
Wassenburg Medical B.V
Wassenburg WD440 and WD440 PT Endoscope Washer Disinfectors
Advice regarding a software upgrade. HPRA Ref: V23795
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Date Printed: 01/05/2024