Accuray Cyberknife treatment system recalled for collimator drop hazard
What this means
In some cases, the collimator (a precision component) may not fully dock into the Cyberknife system. If operators bypass the safety interlock by using the in-room control pendant, the collimator can release and fall from the machine housing. This affects 48 Cyberknife units worldwide running software version 11X or earlier.
- If you operate a Cyberknife system, contact Accuray Incorporated for guidance on affected units and required action.
- Do not use the in-room control pendant to initiate motion if the system interlock is active.
- Ensure clinical staff are aware of this hazard and follow updated safety procedures from Accuray.
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-2640-2026More Accuray Incorporated recalls
- FDA-Device2026-07-08Accuray Cyberknife Treatment System recalled for collimator fall hazard
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