BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0137-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0137-2017
    Event ID
    75239
    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
    October 26, 2016
    Initiation Date
    January 30, 2016
    Classification Date
    October 19, 2016
    Termination Date
    October 5, 2020
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

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

    Reason

    The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.

    Code Info

    Versions prior to 5.2.9

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.

    Quantity

    844 sites potentially have the affected versions