- Recalling firm
- Accuray Incorporated
- 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.
- Affected products (lot / model / serial)
- ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.
- Units affected
- 292 units
- Distribution pattern
- 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.
- Firm location
- Madison, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2644-2026
- Recall initiated
- June 16, 2026
- FDA classification date
- July 1, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99083
- Last updated on HTM Vibe
- July 23, 2026