Medical Device Recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Accuray Incorporated · June 16, 2026
Reason for Recall
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.
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, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
States Affected
NATIONWIDE
Quantity Affected
292 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2644-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.