BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

    Recall: Z-2268-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2268-2019
    Event ID
    83377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    July 3, 2019
    Classification Date
    August 14, 2019
    Termination Date
    May 10, 2024
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

    Reason

    Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

    Code Info

    Serial Numbers: 98474 92280 92261 65370 66032 66649 65299 92298 64516 92335 92300 66062 64218 92313 92296 92254 64051 92342 92277 92307 92336 92315 92288 98473 65145 65493 92323 92321 92243

    Distribution

    US Nationwide distribution.

    Quantity

    N/A