BEUDAMED
    FDA Recall Terminated

    Calculator/Data Processing Module for Clinical Use

    Recall: Z-0007-04 · Initiated August 12, 2003

    Recall

    Recall Number
    Z-0007-04
    Event Number
    27077
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2003
    Posted
    July 20, 2004
    Terminated
    March 15, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Calculator/Data Processing Module for Clinical Use

    Reason

    Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.

    Action

    Product Safety Notice, PSN-03-L37 was issued to all affected clients by facsmile. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.

    Distribution

    Nationwide, UK, Ireland, Canada, Denmark, United Arab Emirates & Bermuda

    Quantity

    479