Accuray recalls TomoTherapy Treatment Systems with specific serial numbers and product codes due to potential dose rotation errors during radiation therapy. Affected units may deliver incorrect radiation doses to patients.
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Accuray is recalling certain TomoTherapy Treatment Systems used for radiation therapy. The system may deliver an incorrect radiation dose to patients due to a 'MLC tickle error' in the software.
The 'MLC tickle error' in the software could cause the delivered radiation dose to rotate from the planned dose. This might result in incorrect radiation delivery to patients during treatment, potentially affecting treatment outcomes.
Patients receiving radiation therapy at medical facilities using the affected TomoTherapy systems. Medical professionals operating the systems are most at risk.
Check if your TomoTherapy system has serial numbers 110210, 110319, 110340, 110366, 110383, 110418, or 110468. Product codes H-0000-0003, 104430, and 1018284 also indicate affected units.
Verify your TomoTherapy system's serial number against the list: 110210, 110319, 110340, 110366, 110383, 110418, 110468.
The recall record states that the 'MLC tickle error' may cause the delivered radiation dose to rotate from the planned dose, but does not explain the technical details.
Check your system's serial number against the list: 110210, 110319, 110340, 110366, 110383, 110418, 110468. Product codes H-0000-0003, 104430, and 1018284 also indicate affected units.
The recall record does not specify a remedy, so no action steps are provided. Contact Accuray directly for further instructions.
We’ve drafted a message you can send Accuray to request your refund or repair — edit it as you like.
Subject: Recall Z-0784-2021 — Accuray Accuray Hello, I own a Accuray that is covered by recall Z-0784-2021 from Accuray. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
