{"recall":{"id":"fda-device-99083","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer","firm":"Accuray Incorporated","date":"2026-06-16","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator","code":"ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.","quantity":"292 units","number":"Z-2644-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"292 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99083","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"166c54980961271a","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99083","record":[{"status":"Ongoing","city":"Madison","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99083","recalling_firm":"Accuray Incorporated","address_1":"1240 Deming Way","address_2":"N/A","postal_code":"53717-1954","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-2644-2026","product_description":"Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator","product_quantity":"292 units","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.","recall_initiation_date":"20260616","center_classification_date":"20260701","report_date":"20260708","code_info":"ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table."}]}}