BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

    Recall: Z-1645-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1645-2015
    Event ID
    71101
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2015
    Initiation Date
    April 20, 2015
    Classification Date
    May 22, 2015
    Termination Date
    September 1, 2016
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406, United States

    Description

    SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

    Reason

    Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

    Code Info

    SOMATOM Emotion 16 (2007) 10165977 with serial numbers: 86514 32490 80553 32552 32530 86406 86558 80542 80461 86405 32512 80441 86431 80467 86425 80442 86429 86557 80434 32581 32637 32597 80448 80431 32624 32469 80446 32578 80430

    Distribution

    Nationwide Distribution including Puerto Rico.

    Quantity

    75