{"url_path":"/fda/device/recalls/Z-2644-2026","section_key":"summary","section_title":"DEVICE Recall: Accuray Incorporated — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-16","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2644-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Accuray Incorporated"},"word_count":164,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2644-2026\n\n**Recalling firm:** Accuray Incorporated\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-16\n**Report date:** 2026-07-08\n\n## Product\nCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator\n\n## Reason\nIn 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.\n\n## Affected lots\nALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.\n\n## Distribution\nWorldwide - 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."}