Accuray recalls TomoTherapy Treatment Delivery System with iDMS due to potential dose rotation error during radiation therapy. Affected units have specific product codes and serial numbers. Contact Accuray for remedy details.
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Accuray is recalling its TomoTherapy Treatment Delivery System with iDMS for radiation therapy. A software error may cause the delivered radiation dose to rotate from the planned dose, potentially affecting treatment accuracy.
The 'MLC tickle error' in the system software may cause the radiation dose to rotate from the planned dose during treatment. This could lead to incorrect radiation delivery to the target tissue, potentially affecting treatment outcomes.
Medical facilities using the TomoTherapy system for radiation therapy are affected. Patients receiving treatment with this system could be at risk if the dose rotation error occurs.
Check for product codes 104430, 1018286, H-0000-0003, 1018283 or system version 1.2 (5.6.2). Serial numbers listed include 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368.
Review the product codes and serial numbers listed in the recall notice to confirm if your system is affected.
The recall affects medical facilities using the TomoTherapy system for radiation therapy. Patients receiving treatment with this system could be at risk if the dose rotation error occurs.
Check the product codes and serial numbers listed in the recall notice to confirm if your system is affected. Contact Accuray for further instructions.
The recall record does not specify a remedy or fix for the 'MLC tickle error'.
We’ve drafted a message you can send Accuray to request your refund or repair — edit it as you like.
Subject: Recall Z-0785-2021 — Accuray Accuray Hello, I own a Accuray that is covered by recall Z-0785-2021 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.
