{"url_path":"/fda/device/recalls/Z-2640-2026","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-2640-2026%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":130,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2640-2026\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 systems prior with software version 11X that utilize the Exchange Table\n\n## Distribution\nWorldwide 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."}