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Summary of Field Safety Notices - February 2019
Notice type:
3rd Party Publications
Date:
01/03/2019
Further Information:
Abbott
Alinity hq Analyzer
Advice regarding the use of the device. HPRA Ref: V38758
Abbott Ireland, Diagnostics Division
ARCHITECT Estradiol Reagent Kit & Alinity i Estradiol Reagent Kit
Advice regarding changes/updates made to instructions for use. HPRA ref: V38670
Abbott Laboratories
CELL-DYN Emerald
Advice regarding a device modification. HPRA Ref: V38877
ArjoHuntleigh AB
Arjo Minstrel floor lift
Advice regarding a device modification. HPRA Ref: V38042
Biometrix Ltd
VARIOUS Temperature Sensor Catheters
Advice regarding a device removal. HPRA Ref: V36711
Boston Scientific
VALITUDE™ CRT-P, ACCOLADE™ Pacemakers, ESSENTIO™ Pacemakers, VISIONIST™ CRT-P, PROPONENT™ Pacemakers, ALTRUA™ 2 Pacemakers
Advice regarding a software upgrade. HPRA Ref: V34084
Boston Scientific
VALITUDE™, VISIONIST™ CRT-P and CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™ CRT-D
Advice regarding a software upgrade. HPRA Ref: V34085
Brainlab
Brainlab Spine & Trauma 3D Navigation 1.0 (subpart of the system “Navigation Software Spine & Trauma 3D, Version 3.0”)
Advice regarding a software upgrade. HPRA Ref: V38881
ConvaTec Limited
Rectal Tubes, Unoversal Drainage Systems, SimpaVac, Sterile Suction
Connecting Tubes, Sterile Connecting Pieces, Suction Handles/Sets
(FilterFlow™/Deltaflo), Oxygen Catheters, Sterile Nasal Oxygen
Cannulas, Sterile Oxygen Connecting Tubes, and Sterile Forceps.
Advice regarding a device removal. HPRA Ref: V38540
Cook Medical
Gunther 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: V38875
Cordis
Cordis Vista Brite and ADROIT Guiding Catheter
Advice regarding a device removal. HPRA Ref: V38714
Draeger
Fabius GS/ GS premium/ MRI/ Plus/ Plus XL/ Tiro. FSN 1
Fabius GS/ GS premium/ MRI/ Plus/ Plus XL/ Tiro. FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33673
Drägerwerk AG & Co. KGaA
Various disposable breathing circuits
Advice regarding the use of the device. HPRA Ref: V38368
Drive
10407R-30 Paediatric Crutch, 10450-30 Double adjustable elbow crutch - Small, 10451-30 Double adjustable elbow crutch - Medium 10452-30, Double adjustable elbow crutch - Adult, 10453-30 Double adjustable elbow crutch - Extra-long, 10454-30 Double adjustable elbow crutch - Adult
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38685
Edwards Lifesciences
Commander Delivery System Models 9610TF20, 9610TF23, 9610TF26, 9610TF29
Advice regarding the use of the device. HPRA Ref: V38760
ELITech B.V.
ELITech V-Twin Analyzer
Advice regarding the use of the device. HPRA Ref: V38276
Eschmann
T Series Operating Tables
Advice regarding the use of the device. HPRA Ref: V33153
Etac
Rullstol Cross, parking brakes
Advice regarding a device modification. HPRA Ref: V37565
Etac AS, Etac Supply Gjøvik
Molift 2-point sling bar
Advice regarding a device modification. HPRA Ref: V38908
Fannin LIP - Galway
Dermatophyte Test Medium (DTC-25)
Advice regarding a device removal. HPRA Ref: V38842
GE Healthcare
CHA Anesthesia and CHA Critical Care
Advice regarding a software upgrade. HPRA Ref: V38782
GE Medical Systems Information Technologies, Inc.
Carescape One
Advice regarding a device removal. HPRA Ref: V38832
Intuitive Surgical Inc.
da Vinci Xi® EndoWrist® Stapler Release Kit
Advice regarding a device removal. HPRA Ref: V31278
Mattes Instrumente GmbH
Reprocessable surgical instruments
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37847
Micrel Medical Devices
Rythmic Evolution
Advice regarding a software upgrade. HPRA Ref: V35138
Randox Laboratories Ltd
Immunoassay Premium, Immunoassay Premium Plus, Liquid Immunoassay Premium
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38710
Rhondium
OVC – CE 621555
Advice regarding a device removal. HPRA Ref: V38640
Roche Diagnostics
BM-Lactate
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38611
Roche Diagnostics
cobas p 612 ADP Nozzle
Advice regarding a device modification. HPRA Ref: V38773
Sequent Medical Inc
WEB Detachment Controller
Advice regarding a device removal. HPRA Ref: V38826
Siemens Medical Solutions USA, Inc., Ultrasound
Acuson NX2 , NX2 Elite, NX3, NX3 Elite
Advice regarding a software upgrade. HPRA Ref: V38703
Smiths Medical ASD, Inc.
Portex® Blue Line Ultra® Tracheostomy Tubes
Advice regarding a device removal. HPRA Ref: V38778
Stanmore Implants Worldwide Ltd
Femoral Heads / msfmh/cc28-3.5
Advice regarding a device removal. HPRA Ref: V38820
Suhulte-Elektronik GmbH
Siss BabyControl. FSN
Siss BabyControl. Attachment
Siss BabyControl. Attachment Update
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38298
Widex A/S
BABY440 hearing aid
Advice regarding a device removal. HPRA Ref: V37228
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Date Printed: 15/11/2024