Accuray Cyberknife Treatment System recalled for collimator fall hazard
What this means
In some cases, the collimator (a precision component) may not fully dock into the Cyberknife treatment system. This triggers a safety interlock that blocks motion from the operator console. However, if staff enter the treatment room and use the in-room control pendant to move the system, the collimator can release and fall from its housing, creating a potential impact hazard.
- Contact Accuray Incorporated if your facility operates a Cyberknife system with software version 11.X or higher using the Xchange Table.
- Do not bypass the operator console interlock by using the in-room pendant when the collimator has not fully docked.
- Wait for Accuray's guidance on a permanent fix or corrective procedure.
The agency's original wording
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2644-2026More Accuray Incorporated recalls
- FDA-Device2026-07-08Accuray Cyberknife treatment system recalled for collimator drop hazard
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