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Summary of Field Safety Notices - October 2015
Notice type:
3rd Party Publications
Date:
03/11/2015
Further Information:
Animas
Animas 2020 and IR 1200 Insulin Pumps - FSN 1
Animas 2020 and IR 1200 Insulin Pumps - FSN 2
Advice regarding a device removal. HPRA Ref: V16047
Beckman Coulter
Access CEA Reagent Kit
Advice regarding a device removal. HPRA Ref: V25918
Biomet 3i
Provide® Protection Caps / Provide Impression Copings
Advice regarding a device removal. HPRA Ref: V25813
Brainlab
Patient Data Manager, Origin Data Management
Advice regarding a software upgrade. HPRA Ref: V25639
BrainLab AG
iPlan RT Image (below v.4.1.2)/ iPlan RT; and BrainSCAN
Advice regarding a software upgrade. HPRA Ref: V25753
Coloplast
Testicular Implants
Advice regarding a device removal. HPRA Ref: V25772
Cook Medical Europe
Beacon Tip Angiographic Catheters
Advice regarding a device removal. HPRA Ref: V24812
DJO Global
RSP Monoblock Fixture
Advice regarding changes/updates made to instructions for use. HPRA Ref: V25747
Ethicon Endo-Surgery LLC
Harmonic ACE+7
Advice regarding a device removal. HPRA Ref: V25731
GCE
Combilite Medical Valve
Advice regarding a device removal. HPRA Ref: V25287
JCM Seating Solutions Limited
JCM Compact Base
Advice regarding changes/updates made to instructions for use. HPRA Ref: V25335
Leica Biosystems
CD10-270-CE-S and CD10-270-CE Novocastrar• Lyophilized Mouse Monoclonal Antibody CD10 Reagents
Advice regarding a device removal. HPRA Ref: V25565
Maquet
HCU 30 Type 2
Advice regarding a device modification. HPRA Ref: V25828
Medifab Limited
Shuttle Discovery
Advice regarding a device modification. HPRA Ref: V25646
Medtronic
Amphirion® Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
Advice regarding a device removal. HPRA Ref: V25927
Medtronic/Covidien
Power Supply for Covidien Shiley Pressure Control Automatic Cuff Controller
Advice regarding a device removal. HPRA Ref: V25686
Mercury Medical
T-Piece resuscitation devices
Advice regarding the use of the device. HPRA Ref: V25727
Micronclean
Syringes for clinical administration of pharmaceutical preparations to patients
Advice regarding the use of the device. HPRA Ref: V25743
Molnlycke Health Care
ProcedurePak® containing BD Plastipak syringes
Advice regarding the use of the device. HPRA Ref: V25949
Olympus KeyMed
Olympus KeyMed OFP-2 Flushing Pump Accessory- MAJ-1606 Instrument Channel Adaptor
Advice regarding a device removal. HPRA Ref: V25490
Ortho Clinical Diagnostics
ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes
Advice regarding the use of the device. HPRA Ref: V25769
Philips Healthcare
Allura Xper FD R.1.2.8
Advice regarding a software upgrade. HPRA Ref: V25642
Philips Healthcare
HeartStart MRx Defibrillator/Monitor
Advice regarding a software upgrade. HPRA Ref: V25744
Precision UK Ltd
CPX Manifolds
Advice regarding a device removal. HPRA Ref: V25938
Prism Medical UK
Prism P136, C136, CP136
Advice regarding a device modification. HPRA Ref: V25705
PROACT Medical Ltd
PROACT Vented Tracheal Tube Guides
Advice regarding a device removal. HPRA Ref: V25647
Randox Laboratories
Liquid Chemistry Control Plus
Advice regarding a device removal. HPRA Ref: V25698
Silimed
Silimed Implants (Various)
Advice regarding a device removal. HPRA Ref: V25657
Stryker
LFIT V40 Tapers, V40 Tapers and PCA Tapers Vitallium Femoral Heads
Advice regarding a device removal. HPRA Ref: V25574
Varian Medical Systems
ARIA Radiation Oncology
Advice regarding a software upgrade. HPRA Ref: V25730
VBM Medizintechnik
Shiley Pressure Control, Cuff controller for Adult and Child
Advice regarding a device removal. HPRA Ref: V25686
Vygon
Y connector code 884.08
Advice regarding a device removal. HPRA Ref: V24718
Wassenburg Medical
Wassenburg WD440 PT Endoscope Washer Disinfector
Advice regarding a software upgrade. HPRA Ref: V25635
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Date Printed: 26/04/2024