Device product
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.
Z-0288-2018
Product summary
- Event
- Event 78686
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-0288-2018
Official wording
Reason: Uncontrolled couch Z-axis movement (descent)
Code information: 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
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
Uncontrolled couch Z-axis movement (descent)