Z-0288-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2018
- Initiation Date
- November 17, 2017
- Termination Date
- July 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units
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.
Reason for Recall
Uncontrolled couch Z-axis movement (descent)
Distribution Pattern
Worldwide Distribution
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