BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2627-2016 · Initiated January 31, 2016

    Recall

    Recall Number
    Z-2627-2016
    Event Number
    74919
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 31, 2016
    Posted
    August 23, 2016
    Terminated
    February 10, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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.

    Action

    Merge Healthcare sent an Urgent Medical Device Recall letter dated January 28, 2016, and via email on January 31, 2013, to all affected customers. the letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. If you have any additional questions call Merge Customer Service at (877) 741-5369. For further questions, please call (262) 367-0700.

    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