BEUDAMED
    FDA Recall Terminated

    ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.

    Recall: Z-1325-06 · Initiated October 31, 2005

    Recall

    Recall Number
    Z-1325-06
    Event Number
    35796
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2005
    Posted
    August 3, 2006
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.

    Reason

    ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.

    Action

    The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.

    Distribution

    Worldwide, including USA and Canada.

    Quantity

    36