BEUDAMED
    FDA Recall Terminated

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    Recall: Z-2439-2015 · Initiated May 27, 2015

    Recall

    Recall Number
    Z-2439-2015
    Event Number
    71395
    Firm
    PTW-Freiburg Lorracher Strasse 7 Freiburg Germany
    FEI Number
    3007360740
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 27, 2015
    Posted
    August 21, 2015
    Terminated
    March 31, 2017

    Description

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    Reason

    In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure.

    Action

    PTW issues Urgent Safety Notice due to an error with firmware version 2.05 of the UNIDOS webline in some cases, especially with the high dose-per-pulse-rates typical for particle therapy, measuring errors can result.

    Distribution

    Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.

    Quantity

    242 firmwares