BEUDAMED
    FDA Enforcement Class II Terminated

    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.

    Recall: Z-2685-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2685-2016
    Event ID
    74924
    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
    September 7, 2016
    Initiation Date
    January 30, 2016
    Classification Date
    August 29, 2016
    Termination Date
    October 15, 2019
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.

    Reason

    Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.

    Code Info

    Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3

    Distribution

    US Distribution to: CO and OK.

    Quantity

    96 sites potentially have the affected versions for both products