{"recall":{"id":"fda-device-99075","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 systems prior with software version 11X that utilize the Exchange Table","quantity":"48 units","number":"Z-2640-2026","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 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.","nationwide":true,"states":[],"units":"48 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=99075","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5aa87e0cc274a451","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=99075","record":[{"status":"Ongoing","city":"Madison","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99075","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 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.","recall_number":"Z-2640-2026","product_description":"Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator","product_quantity":"48 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 systems prior with software version 11X that utilize the Exchange Table"}]}}