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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 092 11 12 000
Date submitted: 11/21/2012
Manufacturer:Radiometer Medical
Device Type:Blood gas analyzer, AQT90 FLEX
Description:AQT90 FLEX, analyzer
Medical Device Identifier:AQT90 software version: V8.4.22
Reason of Field Safety Corrective Action: A buffer overflow may occur on the Main Board during a flush, which takes place when the AQT90 has been idle for more than 6 hours. The overflow could cause the analyzer to enter into an error stage with different error messages and would require a restart of the analyzer to proceed. This stage is known as the “USB software error”. In some situations the analyzer would lose current calibrations requiring a recalibration. This means that the temporary workaround described in the Technical Bulletin – to restart the analyzer when it has been idle for more than six hours – is no longer necessary.
Remedy Action:1. Continue the roll-out of the V8.4.22 software as per TU0087 using V8.4.30 instead of V8.4.22. 2. Upgrade AQT90 FLEX analyzers with V8.4.22 to V8.4.30.
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:NCMDR
Source Ref. Number:7B8A88C3932E3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Radiometer Medical.pdf