Events

Recall of Proton beam therapy system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hitachi America, Ltd., Power Systems Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71056
  • Event Risk Class
    Class 2
  • Event Number
    Z-1838-2015
  • Event Initiated Date
    2015-04-21
  • Event Date Posted
    2015-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135952
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • 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.

Device

Proton beam therapy system
  • Model / Serial
    No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution in US (Texas) and Japan
  • Product 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.
  • Manufacturer
    Hitachi America, Ltd., Power Systems Division

Manufacturer

Hitachi America, Ltd., Power Systems Division
  • Manufacturer Address
    Hitachi America, Ltd., Power Systems Division, 1840 Old Spanish Trl, Houston TX 77054-2002
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    USFDA