Accuray Incorporated: Accelerator, Linear, Medical
Recall Summary Accuray is recalling certain Cyberknife radiation treatment systems and linear accelerators worldwide because a collimator (a component that shapes radiation beams) may fail to fully dock properly. When this happens, the system's safety lock prevents operation from the main console, but if someone uses the in-room control pendant to start motion anyway, the collimator can detach and fall from the equipment. This recall affects medical facilities across the US and numerous countries internationally.
- Recalling firm
- Accuray Incorporated
- Product
- Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-16
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/cb9e03ae-0fb4-4bc5-82b3-928e52cf9352