BEUDAMED
    FDA Recall Terminated

    Mammomat Inspiration with Tomosynthesis functionality

    Recall: Z-0888-2016 · Initiated February 12, 2016

    Recall

    Recall Number
    Z-0888-2016
    Event Number
    73307
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OTE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 12, 2016
    Terminated
    November 8, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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

    Action

    Siemens sent a Field Safety Notice dated February 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. How will the issue finally be resolved? Siemens is releasing a field modification to resolve this issue as soon as possible. The upgrade software (VB30P) will be available to the affected customers free of charge. A Siemens service engineer will contact you to schedule implementation of the modification for your system. According to regulations set forth in 21 CFR 7.49(d), we advise that you follow the instructions in this notice and where necessary request that you promptly notify and instruct all the staff at your organization who have to be aware of this problem. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. We thank you for your cooperation. For further questions, please call (610) 448-6478.

    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