BEUDAMED
    FDA Recall Terminated

    PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Recall: Z-1838-2015 · Initiated April 21, 2015

    Recall

    Recall Number
    Z-1838-2015
    Event Number
    71056
    Firm
    Hitachi America, Ltd., Power Systems Division
    FEI Number
    3003993895
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 21, 2015
    Posted
    July 18, 2015
    Terminated
    March 24, 2016
    Address
    1840 Old Spanish Trl, Houston, TX, 77054-2002

    Description

    PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Reason

    At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.

    Action

    The recalling firm notified the one consignee about the incident that occurred in Japan on 4/7/15, then gave them an update on 4/13/15 and 4/21/15. The written notification had details for the consignee on how to prevent the device from malfunctioning. The recalling firm also had held conversations with the consignee to discuss the issue and revised work instructions via telephone conference and on site Hitachi personnel.

    Distribution

    Distribution in US (Texas) and Japan

    Quantity

    3