Company: Radiometer America, Inc,
Date of Enforcement Report:8/16/2006
Class:lIl
PRODUCT
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06
REASON
ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched..
CODE
Software Versions 5.21 i.e. ABL8xx 754R00xx N0xx
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by memo and visits beginning on October 31, 2005.
Manufacturer: Radiometer Medical Aps, Bronshoj, Denmark. Firm initiated recall is complete
VOLUME OF PRODUCT IN COMMERCE
36 analyzers
DISTRIBUTION
Nationwide and Internationally
