BEUDAMED
    FDA Recall Terminated

    ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815

    Recall: Z-0441-2022 · Initiated December 9, 2021

    Recall

    Recall Number
    Z-0441-2022
    Event Number
    89228
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 9, 2021
    Terminated
    May 4, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815

    Reason

    Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury

    Action

    Siemens issued Urgent Medical Device Corrction Letter CSAN TH001/21/S on 12/09/2021 to inform them of the potential issue and associated risk. Acton to take: 1. Carefully verify all planned treatment parameters against those actually set during patient setup before treating a patient. 2. Choose one of the following workflow options: - Use absolute table positions. In this case, positioning on a different isocenter would not match the planned table values and the system would prompt an override request. This minimizes the risk of selecting a wrong site fraction group. Or - In the case of mulitple sites, select and download one site at a time from ARIA. In this case, RTT would only display one site. Or - Create a multiple isocenter plan in ARIA. RTT cross checks table positions and selected isocenter coordinates. Siemens also recommends consulting the your system s Instructions for Use, Chapter 3.3.4, One treatment plan divided into two plans . The workflow described in this section prevents the occurrence of the reported incident. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understood the content therein. Siemens Healthineers is not planning a correction for this (potential) issue. The intent of this Customer Safety Advisory Notification is to remind you of the importance to diligently verify the correct treatment parameters when multiple sites get loaded into the RT Therapist.

    Distribution

    US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.

    Quantity

    13 units