Accuray recalls CyberKnife M6 Systems with specific serial numbers due to potential manufacturing variations that could lead to premature component failure. Affected units include 60+ models with serial numbers starting with C0330 to C0464.
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
Accuray is recalling CyberKnife M6 Systems with specific serial numbers because manufacturing variations in the robot's wrist components could cause premature failure. This affects medical devices used for radiation treatment planning and targeted radiation therapy.
The recall involves two manufacturing variations in how the robot's wrist is fastened and cast. These variations may cause the component to fail prematurely, potentially disrupting radiation treatment procedures.
Medical professionals using CyberKnife M6 Systems for radiation treatment planning and stereotactic radiosurgery are most at risk. The recall targets specific serial numbers of the CyberKnife M6 Systems.
Check if your CyberKnife M6 System has a serial number starting with C0330 through C0464. The product is used for radiation treatment planning and stereotactic radiosurgery.
Verify your CyberKnife M6 System's serial number to see if it matches the list of affected numbers starting with C0330 through C0464.
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and casting of the wrist for the robot, which may result in premature failure of the component.
Check your CyberKnife M6 System's serial number to see if it is in the list of affected numbers starting with C0330 through C0464. If it is, contact Accuray for further instructions.
The recall record does not specify a remedy or fix for the manufacturing variations.
We’ve drafted a message you can send Accuray to request your refund or repair — edit it as you like.
Subject: Recall Z-0408-2019 — Accuray Accuray Hello, I own a Accuray that is covered by recall Z-0408-2019 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.
