BEUDAMED
    FDA Recall Terminated

    Calculator/ Data Processing Module for Clinical Use

    Recall: Z-1240-03 · Initiated July 23, 2003

    Recall

    Recall Number
    Z-1240-03
    Event Number
    27039
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 23, 2003
    Posted
    October 15, 2003
    Terminated
    April 23, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Calculator/ Data Processing Module for Clinical Use

    Reason

    Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.

    Action

    Notification to all affected customers was sent by fax on 07/23/03 under PSN-03-L35, with the problem description, effective workaround and estimated release of coding modifications to the software version impacted.

    Distribution

    Nationwide

    Quantity

    466