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FDAClass II · Medical device · Recalled July 8, 2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated
Hazard: 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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2644-2026
- Brand
- Accuray Incorporated
- Classification
- Class II
- Units affected
- 292 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Affected products
Companies & origin
- Recalling firm location
- Madison, WI, United States
- Firm address
- 1240 Deming Way, N/A, 53717-1954
Identifying details (verbatim from the notice)
- Product codes / lots
- ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 99083
- Recall initiated
- June 16, 2026
- FDA classified
- July 1, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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