- 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 systems prior with software version 11X that utilize the Exchange Table
- Units affected
- 48 units
- Distribution pattern
- 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.
- 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-2640-2026
- Recall initiated
- June 16, 2026
- FDA classification date
- July 1, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99075
- Last updated on HTM Vibe
- July 23, 2026