BEUDAMED
    FDA Recall Terminated

    Horizon Medical Imaging, Picture Archive Communication System (PACS).

    Recall: Z-0976-2014 · Initiated December 23, 2013

    Recall

    Recall Number
    Z-0976-2014
    Event Number
    67374
    Firm
    Mckesson Information Solutions LLC
    FEI Number
    3002684279
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 23, 2013
    Posted
    February 12, 2014
    Terminated
    April 25, 2017
    Address
    5995 Winward Plaza, Information Technology Business Alpharetta, GA, 30005

    Description

    Horizon Medical Imaging, Picture Archive Communication System (PACS).

    Reason

    Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.

    Action

    McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.

    Distribution

    U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.

    Quantity

    618 units