BEUDAMED
    FDA Recall Terminated

    ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

    Recall: Z-1214-2017 · Initiated January 25, 2017

    Recall

    Recall Number
    Z-1214-2017
    Event Number
    76454
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 25, 2017
    Terminated
    October 1, 2018
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

    Reason

    Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

    Action

    Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 7, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Siemens will contact customers to arrange a date for the installation of the software update.

    Distribution

    United States distribution

    Quantity

    194 systems