BEUDAMED
    FDA Enforcement Class II Terminated

    Mammomat Inspiration with Tomosynthesis functionality

    Recall: Z-0888-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0888-2016
    Event ID
    73307
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    February 12, 2016
    Classification Date
    February 25, 2016
    Termination Date
    November 8, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Mammomat Inspiration with Tomosynthesis functionality

    Reason

    A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The syste

    Code Info

    Model number: 10140000

    Distribution

    Nationwide Distribution including Puerto Rico and to the states of : AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA and WI.

    Quantity

    76 units