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Summary of Field Safety Notices - November 2019
Notice type:
3rd Party Publications
Date:
03/12/2019
Further Information:
Summary of Field Safety Notices - November 2019
Baxter
Artiset HD DNL HC; Artset pre-post
Advice regarding a device removal. HPRA Ref: V41990
Beckman Coulter Ireland Inc.
iQ200 Series Urine Microscopy Analyser and iChemVELOCITY Urine Chemistry System
Advice regarding the use of the device. HPRA Ref: V41954
Biomerieux UK
BACT/ALERT VIRTUO
Advice regarding a device modification. HPRA Ref: V41987
Cepheid AB
Xpert HIV-1 Viral Load
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42210
Cordis Healthcare
Cordis S.M.A.R.T. and PRECISE Stents
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42040
Elekta
Flexitron
Advice regarding the use of the device. HPRA Ref: V42181
Ethicon
LIGAMAX – 5mm Endoscopic Multiple Clip Applier
Advice regarding a device removal. HPRA Ref: V42056
Flowonix
LIGAMAX – 5mm Endoscopic Multiple Clip Applier
Advice regarding the use of the device. HPRA Ref: V42171
Gas Control Equipment
MediEject II
Advice regarding a device modification. HPRA Ref: V42098
GE Healthcare
Centricity High AcuitAnesthesia and Centricity High Acuity Critical Care Systems
Advice regarding a software upgrade. HPRA Ref: V42164
CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) and the Airway Gas Option (N-CAiO)
Advice regarding a device removal. HPRA Ref: V42211
GE Medical
ApexPro Telemetry System
Advice regarding a software upgrade. HPRA Ref: V42086
Gore
DrySeal Flex Introducer Sheath
Advice regarding a device removal. HPRA Ref: V42188
Haemonetics
123ml and 225ml Cell Saver Centrifuge Bowls
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42008
Imtmedical
Bellavista Ventilators 1000, 1000 NEO, 1000e, 1000 Set
Advice regarding a software upgrade. HPRA Ref: V42057
Bellavista Ventilators 1000XX, 950
Advice regarding a software upgrade. HPRA Ref: V42088
Inion Oy
Inion Thermo Drape
Advice regarding a device removal. HPRA Ref: V42279
Invacare
Invacare® Birdie® EVO Lifter
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41926
Laboratoire CCD
1ml IVF and AI Syringes
Advice regarding a device removal. HPRA Ref: V42165
Labratories Anios
Various Medical Devices Disinfectants
Advice regarding a device removal. HPRA Ref: V42097
Lohmann & Rauscher GmbH & Co KG
Meche de Gaze
Advice regarding a device removal. HPRA Ref: V41435
MediFab
Shuttle Discovery Roller
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41476
Medisoft Limited
‘Medisoft Ophthalmology’ Electronic Medical Record
Advice regarding a software upgrade. HPRA Ref: V42119
Medtronic
Passive Biopsy Needle Kit - Model Number 9733068 Passive Biopsy FPU Kit - Model Number 9731754
Advice regarding a device removal. HPRA Ref: V41995
Claria MRI™/Amplia MRI™/Compia MRI™ CRT-Ds, Viva™/Brava™ CRT-Ds, Visia AF™/Visia AF MRI™ ICDs, Evera™/Evera MRI™/Primo MRI™/Mirro MRI™ ICDs
Advice regarding the use of the device. HPRA Ref: V42168
MiniMed 640G Insulin Pump; MiniMed 670G Insulin Pump
Advice regarding the use of the device. HPRA Ref: V42217
Medtronic Inc.
Activa Clinician Programmer Application - FSN
Activa Clinician Programmer Application - Updated instructions
Advice regarding a software upgrade. HPRA Ref: V39488
Olympus
NEW INSTRUCTIONS FOR SAFE USE FOR SEVERAL OLYMPUS DUODENOVIDEOSCOPES & DUODENOFIBERSCOPES
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42162
Philips Respironics
Trilogy Evo/Garbin Evo/LifeVent Evo2 ventilators
Advice regarding a software upgrade. HPRA Ref: V42215
Randox laboratories Ltd.
NEFA
Advice regarding a device removal. HPRA Ref: V41511
Roche Diabetes Care
Elecsys Troponin T hs. See under "Accessories" - FSN
Elecsys Troponin T hs. See under "Accessories" - FSN2
Advice regarding the use of the device. HPRA Ref: V41986
Accu-Chek Aviva glucose meter
Advice regarding the use of the device. HPRA Ref: V42047
Siemens
Atellica CH 930 Analyzer
Advice regarding a device modification. HPRA Ref: V41728
Stago
Various STA Devices
Advice regarding a device removal. HPRA Ref: V42143
Stryker
Sliding Core UHMPWE - STAR Ankle Prosthesis
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V41910
Thermoscientific
Thermo Scientific Remel E. coli Polyvalent Agglutinating Sera
Advice regarding a device removal. HPRA Ref: V42062
USF Healthcare
Unisepta Foam 2
Advice regarding a device removal. HPRA Ref: V42117
Xodus Medical
Cautery Tip Cleaner
Advice regarding a device removal. HPRA Ref: V42227
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Date Printed: 26/04/2024