BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0976-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0976-2014
    Event ID
    67374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Information Solutions LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    December 23, 2013
    Classification Date
    February 12, 2014
    Termination Date
    April 25, 2017
    Address
    5995 Winward Plaza, Information Technology Business, Alpharetta, GA, 30005, United States

    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.

    Code Info

    HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.

    Distribution

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

    Quantity

    618 units