BEUDAMED
    FDA Recall Terminated

    Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer

    Recall: Z-0115-2007 · Initiated July 6, 2006

    Recall

    Recall Number
    Z-0115-2007
    Event Number
    36539
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 6, 2006
    Posted
    October 28, 2006
    Terminated
    November 18, 2011
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer

    Reason

    Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.

    Action

    The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.

    Distribution

    Worldwide-The six USA units (equpped with Radiance software) were distributed to a total of two (2) U.S. customers: University of Missouri Hospitals and Clinics in Columbia, MO (4 units) and Vail Valley Medical Center, Vail, CO (2 units). World wide accounts pending submission. Three (3) Canadian customers. They are: 1) Seven Oaks General Hospital MB Canada; and 2) St. Mary''s General Hospital, 911 Queens Blvd, Ontario Canada; and 3) University of Alberta Hospital, 84440 112th Street, Alberta, Canada.

    Quantity

    5 units