BEUDAMED
    FDA Recall Terminated

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    Recall: Z-3005-2020 · Initiated August 19, 2020

    Recall

    Recall Number
    Z-3005-2020
    Event Number
    86185
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 19, 2020
    Terminated
    April 19, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    Reason

    Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location

    Action

    Siemens Medical Solutions USA, Inc. issued Customer Safety Advisory Letter (CSAN) SY051/20/S on August 19, 2020 via email/hand delivery by Siemens Customer Service Engineer,. The letter states reason for recall, health risk and action to take: we highly recommend performing the laser calibration and the quality assurance procedure for the laser offset after every RT Image Suite software update.Please update the calibration offset in the MM RT Image Suite Configuration dialog accordingly . Details of this procedure are documented in Chapter 13.2 (Laser configuration) of your user manual. If you have any questions or require technical support, please contact our service organization at 1-800-888-7436. The technical solution distributed via SY040/20/S. Distribution of SY040/20/S (VB40B_HF01) will be distributed to all affected customers, free of charge. Distribution of SY040/20/S began on August 26, 2020. SY040/20/S will be installed with support from your local service organization

    Distribution

    US Nationwide distribution.

    Quantity

    64 systems US