FDA recall Z-0288-2018

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.

Reason for recall

Uncontrolled couch Z-axis movement (descent)

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2018-01-03

Termination date

2021-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2018