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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 018 07 12 000
Date submitted: 7/8/2012
Manufacturer:Radiometer Medical
Device Type:Blood gas analyzer, ABL80 FLEX (with FLEX SW) and ABL80 FLEX CO-OX (with CO-OX software)
Description:Blood gas analyzer
Medical Device Identifier:Software version: 933-082 SW and 933-132 SW
Reason of Field Safety Corrective Action:The impact of low pO2 levels on the linearity characteristics of the glucose sensor is not always taken into consideration when interpreting the glucose results.. The linearity dependency is described in the reference manual.
Remedy Action:the Operators manual will be distributed to all customers to emphasize the issue related to potential impact on glucose measurements when pO2 is low. Radiometer is developing a software update that will flag glucose results that fall outside the linearity specification limitations. Updates to analyzers soft ware and associated operators manual will be distributed to customers when the software becomes available.
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:NCAR
Source Ref. Number:DK-2012-07-03-013
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments