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Accuray Incorporated recalls Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as
Recalled January 3, 2018 · FDA recall Z-0286-2018 · Accuray Incorporated
Hazard
Uncontrolled couch Z-axis movement (descent) · FDA Class II
Units
250 units
Sold at
Worldwide Distribution
Description
Uncontrolled couch Z-axis movement (descent)
Product
Hi-Art(R) System, Model Number H-000-0003 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.
Manufacturer(s)
Accuray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →