BEUDAMED
    FDA Enforcement Class II Terminated

    Merge OrthoPACS software.

    Recall: Z-2620-2017 · Reported June 28, 2017

    Enforcement

    Recall Number
    Z-2620-2017
    Event ID
    77265
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 28, 2017
    Initiation Date
    May 24, 2017
    Classification Date
    June 22, 2017
    Termination Date
    June 28, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge OrthoPACS software.

    Reason

    A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

    Code Info

    Versions 6.6, 6.6.1, and 6.6.2

    Distribution

    Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.

    Quantity

    98 sites potentially have the affected versions