BEUDAMED
    FDA Recall Terminated

    Axiom Sensis. Programmable Diagnostic Computer

    Recall: Z-0979-03 · Initiated February 28, 2003

    Recall

    Recall Number
    Z-0979-03
    Event Number
    25930
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2003
    Posted
    July 3, 2003
    Terminated
    April 8, 2004
    Address
    51 Valley Stream Parkway, Malvern, PA, 19355

    Description

    Axiom Sensis. Programmable Diagnostic Computer

    Reason

    software problem - erroneous results or system crashes

    Action

    The recalling firm issued a Customer Safety Advisory Letter to their customers. The letter instructed the customer to insert the letter into their operator''s manual and that updated software would be released in May 2003.

    Distribution

    The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.

    Quantity

    4 units