My HPRA: Register

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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