BEUDAMED
    FDA Recall Terminated

    Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.

    Recall: Z-1262-06 · Initiated March 2, 2005

    Recall

    Recall Number
    Z-1262-06
    Event Number
    35699
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 2, 2005
    Posted
    July 27, 2006
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.

    Reason

    Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.

    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.

    Distribution

    Nationwide.

    Quantity

    306 units