Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.
FDA Recall Z-1262-06 · Posted 2006-07-27
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2005-03-02
Date Terminated2012-02-24
Product Quantity306 units
Reason for Recall
Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
Firm Action
The firm initiated this recall with letters to their customers on 3/2/2005. After this notification, the firm''s Field Service Reps visited each affected customer and updated their software to version 2.42. According to the firm, these actions took place from 3/12/2005 thru 4/15/2005. The Field Reps. of Radiometer America reported to Radiometer Medical ApS in Denmark that the necessary corrections had been competed as of: 4/15/2005.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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