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Summary of Field Safety Notice – May 2015
Notice type:
3rd Party Publications
Date:
04/06/2015
Product name or type:
Summary of Field Safety Notice – May 2015
Further Information:
Abbott Diagnostics
Alkaline Wash
Advice regarding a device removal. HPRA Ref: V24257
ArcRoyal
Devon Light Glove
Advice regarding a device removal. HPRA Ref: V24276
Beckman Coulter
Access 2 Immunoassay Systems
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24072
Beckman Coulter
UniCel DxI Immunoassay Systems
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24074
Biomet
Optigun Ratchet
Advice regarding a device removal. HPRA Ref: V24209
Boston Scientific
Extractor™ Pro RX Retrieval Balloon Catheter
Advice regarding a device removal. HPRA Ref: V24138
CareFusion
Avea Ventilator
Advice regarding a device modification. HPRA Ref: V24077
DePuy International Limited
RECLAIM® Assembled Implant Inserter Adaptor
Advice regarding a device removal. HPRA Ref: V23823
GE Healthcare
Centricity PACS
Advice regarding a software upgrade. HPRA Ref: V24166
Hamilton Medical
Hamilton Infant Flow Sensor, Single Use
Advice regarding the use of the device. HPRA Ref: V24261
Idoman Teoranta
Thermablate EAS System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23397
Keeler Opthalmic Instruments
Keeler Wall Plug Power Supply
Advice regarding a device modification. HPRA Ref: V23640
Maquet
MAGNUS Hybrid OR table column 1180.01B2
Advice regarding a software upgrade. HPRA Ref: V24345
Medtronic-Covidien
Devon Light Glove
Advice regarding a device removal. HPRA Ref: V24025
Medtronic-Covidien
OxiMax N-65 Handheld Pulse Oximeter and OxiMax N-560 Pulse Oximeter
Advice regarding the use of the device. HPRA Ref: V24011
Natus
neoBLUE Blanket System
Advice regarding the use of the device. HPRA Ref: V23854
Ortho-Clinical Diagnostics
ORTHO VISION™ Analyzer
Advice regarding the use of the device. HPRA Ref: V24202
Ortho-Clinical Diagnostics
ORTHO VISION™ Analyzer
Advice regarding a software upgrade. HPRA Ref: V24290
OrthoSolutions
CIS Plate Standard/Heavy Duty/Extra Heavy Duty 130 Deg
Advice regarding a device removal. HPRA Ref: V23553
PerkinElmer
WIZARD2 Barcode ID Label #023 Content
Advice regarding a device removal. HPRA Ref: V24304
Philips
Philips devices with ASV therapy
Advice regarding the use of the device. HPRA Ref: V24344
Philips Healthcare
Philips IntelliVue Information Center iX
Advice regarding a software upgrade. HPRA Ref: V24161
Philips Healthcare
EPIQ 5 Ultrasound System v1.3.2 or lower
Advice regarding a software upgrade. HPRA Ref: V24127
Philips Healthcare
EPIQ 5 Ultrasound System with Pediatric Cardiology v1.3.2 or lower
Advice regarding a software upgrade. HPRA Ref: V24123
Philips Healthcare
DigitalDiagnost 4.0.x
Advice regarding a software upgrade. HPRA Ref: V24164
Resmed
Resmed devices with ASV therapy
Advice regarding the use of the device. HPRA Ref: V24266
Roche
CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL/TG, TRIGGB, TRIG/GB, CHOL/CHOL2, HDL-C plus 3rd generation/HDLC3, LDL_C plus 2nd generation/LDL_C, UA2/UA plus
Advice regarding the use of the device. HPRA Ref: V24201
Roche
S3 Fluid Pack A Transponder
Advice regarding the use of the device. HPRA Ref: V24364
Roche Diabetes Care
Accu-Chek Spirit Combo insulin pump & Accu-Chek Spirit insulin pump
Advice regarding the use of the device. HPRA Ref: V24017
Roche Diabetes Care
Accu-Chek Spirit Combo insulin pump & Accu-Chek Spirit insulin pump
Advice regarding the use of the device. HPRA Ref: V24017
Sekisui Diagnostics
Sekisui Diagnostics Acetaminophen
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24211
Siemens
ADVIA Centaur, ADVIA Centaur® XP, ADVIA Centaur® XPT, ADVIA Centaur® CP
Advice regarding the use of the device. HPRA Ref: V24334
Siemens AG
Digital Linear Accelerators of type PRIMUS and ONCOR - Control Console Software Update to v9.2.400
Advice regarding a software upgrade. HPRA Ref: V24156
Siemens AG
Multix Swing X-Ray
Advice regarding a device modification. HPRA Ref: V24224
Siemens AG
Artis Systems
Advice regarding a device modification. HPRA Ref: V24199
Siemens Healthcare
RAPIDLab® 1260/1265 Systems
Advice regarding a software upgrade. HPRA Ref: V24189
Teleflex Medical
Hudson RCI Lifesaver Neonate Manual Resuscitator
Advice regarding a device removal. HPRA Ref: V24279
Teleflex Medical
Hudson RCI© SHERIDAN SHER-I-BRONCH® Endobronchial Tube
Advice regarding a device removal. HPRA Ref: V24366
Terumo Europe N.V.
Terumo® Radifocus Guide Wire M
Advice regarding a device removal. HPRA Ref: V24175
UnoMedical
SURE-T, SURE-T Paradigm, contact detach, contact, Sub Q, neria, neria detach, neria multi, thalaset
Advice regarding the use of the device. HPRA Ref: V24336
Vision RT
Align RT
Advice regarding a software upgrade. HPRA Ref: V22342
X-BOLT® Orthopaedics
Screwdriver, 3.5mm – hex, 4.5Nm torque limit
Advice regarding the use of the device. HPRA Ref: V24296
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Date Printed: 27/07/2024