Accuray recalls CyberKnife M6 treatment systems with specific part numbers and serials due to risk of unintended collimator housing drop during housing exchange workflows.
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
Accuray is recalling CyberKnife M6 radiation treatment systems with specific part numbers and serial numbers. The recall is due to a potential risk of a collimator housing dropping during housing exchange procedures, which could lead to treatment errors.
During automated housing exchanges, an interlock may interrupt the process, causing the collimator housing to partially attach. This could lead to treatment errors if the housing drops unexpectedly during procedures.
Patients and medical staff using CyberKnife M6 systems with the listed part numbers and serial numbers are affected. Those handling the equipment during housing exchanges are at higher risk.
Check the part numbers listed in the recall notice: 0660000, 053101-010, 053201-010, 053301-010, 053401-010, or 053501-010. Also, verify the serial numbers provided for each part number.
Review your CyberKnife M6 system's part numbers and serial numbers against the list provided in the recall notice.
Part numbers 0660000, 053101-010, 053201-010, 053301-010, 053401-010, and 053501-010 are affected.
Serial numbers listed for each part number, such as C0434, C0436, C0437, and others, are affected.
The recall notice does not specify a remedy; users should check their equipment against the list and contact Accuray for further guidance.
We’ve drafted a message you can send Accuray to request your refund or repair — edit it as you like.
Subject: Recall Z-1696-2019 — Accuray Accuray Hello, I own a Accuray that is covered by recall Z-1696-2019 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.
