FDA recall, , Moderate risk
Accuray CyberKnife Treatment Delivery System and Linear Accelerator
The Cyberknife system's collimator may not fully dock, triggering an interlock and preventing motion.
Summary by Recall Canary from the FDA notice
What happened
Accuray Incorporated of Madison, Wisconsin, recalled 48 units of the Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer, a linear accelerator, because 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.
The company began the recall on June 16, 2026, and it was added to the FDA's Enforcement Report on July 1, 2026. The recalled systems were distributed worldwide, including the US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, and Ukraine.
Recall history
FDA filed this recall twice. Each date is when the company began that recall. Each filing is listed with its own quantity; they are not added up.
- Jun 16, 2026 · FDA event 99075 · All systems prior with software version 11X that utilize the Exchange Table · Quantity: 48 units
- Jun 16, 2026 · FDA event 99083 · ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table · Quantity: 292 units
2 photos
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Affected units
- All systems prior with software version 11X that utilize the Exchange TableALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine.
- Company
- Accuray IncorporatedMadison, Wisconsin
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99075
- Recall number
- Z-2640-2026
- Quantity recalled
- 48 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
