BEUDAMED
    FDA Enforcement Class II Terminated

    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    Recall: Z-2301-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2301-2016
    Event ID
    74648
    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
    August 10, 2016
    Initiation Date
    January 30, 2016
    Classification Date
    July 29, 2016
    Termination Date
    April 8, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    Reason

    Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

    Code Info

    Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.

    Distribution

    Worldwide Distribution -- USA, New Zealand, and United Kingdom.

    Quantity

    109 sites have the affected versions