BEUDAMED
    FDA Recall Terminated

    Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module

    Recall: Z-1090-03 · Initiated June 16, 2003

    Recall

    Recall Number
    Z-1090-03
    Event Number
    26678
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2003
    Posted
    August 7, 2003
    Terminated
    April 23, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module

    Reason

    Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.

    Action

    The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003.

    Distribution

    Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia.

    Quantity

    315