Events

Recall of Device Recall TomoHD(R) 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
    78686
  • Event Risk Class
    Class 2
  • Event Number
    Z-0287-2018
  • Event Initiated Date
    2017-11-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160116
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Uncontrolled couch z-axis movement (descent).
  • Action
    Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated the following: "Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem." For questions contact Accuray Customer Support by phoning the regional support lines.

Device

Device Recall TomoHD(R) System
  • Model / Serial
    Serial Numbers: 110081 110100 110158 110180 110185 110194 110197 110208 110214 110228 110265 110266 110268 110286 110300 110311 110315 110332 110333 110347 110350 110354 110355 110357 110363 110368 110376 110378 110379 110380 110381 110385 110386 110387 110388 110390 110391 110392 110394 110396 110397 110401 110402 110405 110406 110407 110409 110412 110413 110414 110415 110419 110420 110422 110425 110426 110427 110430 110431 110434 110436 110437 110441 110442 110444 110445 110446 110447 110448 110451 110453 110454 110455 110458 110460 110464 110465 110466 110467 110469 110471 110472 110480 110482 110501 110504 110506 110511 110512 110517 110527 110528 110531 110532 110534 110539 110540 110541 110544 110545 110546 110547 110548 110549 110553 110555 110558 110563 110566 110569 110574 110578 110579 110591 110594 110596 110597 110606
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    TomoHD(R) System, Model Number 1018283 || Product Usage: || The TomoTherapy treatment system is intended to be used as an integrated system for t he 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 tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and 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