BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2627-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2627-2016
    Event ID
    74919
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 31, 2016
    Initiation Date
    January 31, 2016
    Classification Date
    August 23, 2016
    Termination Date
    February 10, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

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

    Reason

    Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.

    Code Info

    Versions: 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E, SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, and 5.35.4 HF0513

    Distribution

    Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.

    Quantity

    25 sites potentially have the affected versions