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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