BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).

    Recall: Z-0556-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0556-2014
    Event ID
    67014
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Information Solutions LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    October 15, 2013
    Classification Date
    December 20, 2013
    Termination Date
    June 3, 2014
    Address
    5995 Winward Plaza, Information Technology Business, Alpharetta, GA, 30005, United States

    Description

    McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).

    Reason

    When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.

    Code Info

    MR 12.0

    Distribution

    MO, NY, TN, WV and France.

    Quantity

    6 units