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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 157 09 12 000
Date submitted: 9/25/2012
Manufacturer:Radiometer Medical
Device Type:Blood gas analyzer,, ABL80 FLEX analyzer
Description:Blood gas analyzer
Medical Device Identifier: A QUALICHECK4+ Level 4 (S7460) range study for the ABL80 with FLEX software Beginning with S7460 Lot 65, all ABL80 analyzers with FLEX software
Reason of Field Safety Corrective Action: If a user scans the insert barcode for lot 65 or higher and the analyzer was not upgraded to software v1.28 (or higher) then the scanned range for pO2 will be incorrect. The analyzer will provide no warning that the range is incorrect.
Remedy Action:For specific customers considering any of the software bug fixes to be important we recommend that the ABL80 FLEX analyzer software is upgraded to V1.28
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:NCMDR
Source Ref. Number:FBCFD33CE03B9
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Radiometer Medical (1).pdf