Device Recall TomoH(R) System

  • Model / Serial
    Serial Numbers: 110040 110083 110163 110231 110237 110289 110302 110369 110418 110461 110462 110474 110491 110494 110503 110519 110525 110533 110536 110537 110552 110554 110556 110562 110565 110570 110573 110576 110577
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    TomoH(R) System, Model Number 1018284 || 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
  • 1 Event

Manufacturer

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