{"recall":{"id":"fda-device-99141","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"RAYSEARCH LABORATORIES AB recalls 2 products","firm":"RAYSEARCH LABORATORIES AB","date":"2026-05-20","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"RayCare 2024A SP1. Oncology Information Systems.","code":"Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24","quantity":"3 units","number":"Z-2646-2026","classification":"Class II"},{"name":"RayCare 2024A SP4. Oncology Information Systems.","code":"Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.","quantity":"3 units","number":"Z-2647-2026","classification":"Class II"}],"reason":"Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution.","nationwide":true,"states":[],"units":"3 units; 3 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=99141","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"493dffd5e211ce0a","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=99141","record":[{"status":"Ongoing","city":"Stockholm","state":"N/A","country":"Sweden","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99141","recalling_firm":"RAYSEARCH LABORATORIES AB","address_1":"Eugeniavagen 18c","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-2646-2026","product_description":"RayCare 2024A SP1. Oncology Information Systems.","product_quantity":"3 units","reason_for_recall":"Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.","recall_initiation_date":"20260520","center_classification_date":"20260701","report_date":"20260708","code_info":"Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24"},{"status":"Ongoing","city":"Stockholm","state":"N/A","country":"Sweden","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99141","recalling_firm":"RAYSEARCH LABORATORIES AB","address_1":"Eugeniavagen 18c","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-2647-2026","product_description":"RayCare 2024A SP4. Oncology Information Systems.","product_quantity":"3 units","reason_for_recall":"Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.","recall_initiation_date":"20260520","center_classification_date":"20260701","report_date":"20260708","code_info":"Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24."}]}}