Events

Recall of Device Recall HiArt System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Accuray Incorporated.

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
    59427
  • Event Risk Class
    Class 2
  • Event Number
    Z-3163-2011
  • Event Initiated Date
    2011-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102766
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Tomotherapy inc. is sending this field safety notice to make you aware of an anomaly which may affect the performance of the tomomobile hi-art system. tomotherapy has discovered that when attempting to open the tomomobile shielding doors, while the door hinges are in the locked position, the hinges may fail allowing the door to disengage from the shielding.
  • Action
    The firm, TomoTherapy, sent an "Urgent Medical Device Correction" letter dated July 7, 2011 to its consignees/customers. The letter described the Issue, Product Affected, Recommended Action (advised consignees to not attempt to open the shielding doors when the hinges are in the locked position. The Hinges should always be in the unlocked position when opening the doors) and Resolution. A TomoTherapy field service engineer or an authorized service representative will contact the customers when a resolution is available. If you have any questions, please contact the TomoTherapy Technical Solutions Center by email at support@tomotherapy.com or phone at: North America: 1-866-368-4807; Belgium: 0800 38783; France: 0805 631 565; Germany: 0800 000 7541; Italy: 800 986 399; Netherlands: 0800 020 1364; Spain: 800 300049; Switzerland: 0800 001927; United Kingdom: 0808 238 6035; China/CNC (Northern): 10 800 712 1701; China (Southern): 10 800 120 1701; Hong Kong: 800 967912; Japan: 0044 22 132374; Singapore: 800 1204 683; South Korea: 0079 81 4800 7204, all other locations: +1 608 824 2900 or +32 2 400 44 44.

Device

Device Recall HiArt System
  • Model / Serial
    Serial Numbers: 110051 110101 110298 110329
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA and OK; and country of: United Arab Emirates
  • Product Description
    TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 || The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • Manufacturer Address
    Accuray Incorporated, 1240 Deming Way, Madison WI 53717-1954
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    USFDA