BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

    Recall: Z-0948-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0948-2013
    Event ID
    64376
    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 20, 2013
    Initiation Date
    November 27, 2012
    Classification Date
    March 14, 2013
    Termination Date
    January 31, 2014
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

    Reason

    Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

    Code Info

    Model numbers - 7740769, 8098027, 10430603, and 10590000.

    Distribution

    Nationwide Distribution.

    Quantity

    896