BEUDAMED
    FDA Enforcement Class II Terminated

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    Recall: Z-2601-2017 · Reported June 28, 2017

    Enforcement

    Recall Number
    Z-2601-2017
    Event ID
    77271
    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 16, 2017
    Termination Date
    October 15, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    Reason

    Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

    Code Info

    Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2

    Distribution

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

    Quantity

    160 sites potentially have the affected versions