Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TomoTherapy Treatment System Recalled by TomoTherapy Incorporated Due to Accuray is voluntarily recalling TomoTherapy H Series software...
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 TomoTherapy Incorporated directly.
Affected Products
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
Quantity: 322
Why Was This Recalled?
Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About TomoTherapy Incorporated
TomoTherapy Incorporated has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report