Accuray recalls TomoHDA System model 1018286 due to uncontrolled couch descent during radiation therapy. Affected units have specific serial numbers; stop using immediately to prevent injury.
Uncontrolled couch Z-axis movement (descent)
Accuray is recalling its TomoHDA System (model 1018286) because it can move unexpectedly downward during radiation therapy treatments. This poses a risk of serious injury to patients or staff if the movement causes a fall or collision.
The system's couch can move unexpectedly downward during radiation therapy treatments. This uncontrolled descent could cause a patient or staff member to fall or collide with equipment, leading to serious injury.
Medical facilities using the TomoHDA System for radiation therapy treatments are affected. Patients and staff at these facilities are at highest risk due to potential for uncontrolled movement during procedures.
Check if your TomoHDA System has the model number 1018286 and the listed serial numbers (e.g., 110033, 110137, etc.). The product is used in medical facilities for radiation therapy treatments.
Discontinue use of the TomoHDA System until a replacement is installed or the issue is resolved.
The model number is 1018286.
Affected serial numbers include 110033, 110137, 110155, and many others listed in the recall notice.
The system's couch can move unexpectedly downward during radiation therapy treatments, posing a risk of serious injury.
We’ve drafted a message you can send Accuray to request your refund or repair — edit it as you like.
Subject: Recall Z-0289-2018 — Accuray Accuray Hello, I own a Accuray that is covered by recall Z-0289-2018 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.
