Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hi-Art(R) System Recalled by Accuray Incorporated Due to Uncontrolled couch Z-axis movement (descent)
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Accuray Incorporated directly.
Affected Products
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.
Quantity: 250 units
Why Was This Recalled?
Uncontrolled couch Z-axis movement (descent)
Where Was This Sold?
Worldwide Distribution
About Accuray Incorporated
Accuray Incorporated has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report