Accuray Incorporated recalls TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an in…

Recall date

November 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0289-2018

FDA classification

Class II

Brand / firm

Accuray Incorporated

Sold / distributed

Worldwide Distribution

Why it was recalled

Uncontrolled couch Z-axis movement (descent)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TomoHDA(R) System, Model Number 1018286 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.