{"recall":{"id":"fda-device-99817","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5","firm":"Canon Medical System, USA, INC.","date":"2026-08-26","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Alphenix INFX-8000C/B5","code":"Serial no. B5F2532011/UDI: 4987670100192","quantity":"1 unit","number":"Z-0108-2027","classification":"Class II"}],"reason":"Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of ID.","nationwide":true,"states":[],"units":"1 unit","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=99817","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3dc7c4e2f729a30f","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=99817","record":[{"status":"Ongoing","city":"Tustin","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99817","recalling_firm":"Canon Medical System, USA, INC.","address_1":"2441 Michelle Dr","address_2":"N/A","postal_code":"92780-7047","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of ID.","recall_number":"Z-0108-2027","product_description":"Alphenix INFX-8000C/B5","product_quantity":"1 unit","reason_for_recall":"Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error","recall_initiation_date":"20260826","center_classification_date":"20261007","report_date":"20261014","code_info":"Serial no. B5F2532011/UDI: 4987670100192"}]}}