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.
Enforcement
- Recall Number
- Z-0288-2018
- Event ID
- 78686
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Accuray Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 3, 2018
- Initiation Date
- November 17, 2017
- Classification Date
- December 26, 2017
- Termination Date
- July 25, 2021
- Address
- 1240 Deming Way, N/A, Madison, WI, 53717-1954, United States
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.
Uncontrolled couch Z-axis movement (descent)
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
Worldwide Distribution
29 units