Accuray recalls specific TomoH System models due to potential uncontrolled couch descent during radiation therapy. Affected units include serial numbers 110040 to 110577. Immediate action required to prevent injury.
Uncontrolled couch Z-axis movement (descent)
Accuray is recalling certain TomoH System radiation therapy machines because they can move unexpectedly downward during treatment. This could cause serious injury to patients or staff if the machine shifts while delivering radiation. Affected units have specific serial numbers listed in the recall notice.
The TomoH System's treatment couch can move uncontrollably downward during radiation therapy sessions. This uncontrolled descent could cause the patient or staff to be injured by the moving machine or radiation exposure. The hazard occurs when the couch is not properly secured or monitored during treatment.
Healthcare providers using the TomoH System for radiation therapy treatments are most at risk. Patients receiving treatment with these specific models could be harmed if the couch moves unexpectedly.
Check if your TomoH System has a serial number starting with 110040 through 110577. The system is used for radiation therapy planning and delivery in medical facilities.
Immediately cease using the TomoH System with the affected serial numbers to prevent uncontrolled couch movement during treatment.
The TomoH System can move uncontrollably downward during radiation therapy, which could cause injury to patients or staff.
Serial numbers from 110040 to 110577 are affected by this recall.
Check the serial number on your TomoH System; affected units have serial numbers starting with 110040 through 110577.
We’ve drafted a message you can send Accuray to request your refund or repair — edit it as you like.
Subject: Recall Z-0288-2018 — Accuray Accuray Hello, I own a Accuray that is covered by recall Z-0288-2018 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.
