{"recall":{"id":"fda-device-99079","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Siemens Medical Solutions USA, Inc recalls 2 products","firm":"Siemens Medical Solutions USA, Inc","date":"2026-05-20","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"ARTIS icono biplane. Model Number: 11327600.","code":"Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109","quantity":"85 units","number":"Z-2641-2026","classification":"Class II"},{"name":"ARTIS icono floor. Model Number: 11327700.","code":"Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067.","quantity":"30 units","number":"Z-2643-2026","classification":"Class II"}],"reason":"Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"85 units; 30 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=99079","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2ec27a5b51635fa9","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[{"at":"2026-11-02T22:17:07.772Z","changes":["Product details, codes or quantities changed","Units: 85 units; 119 units; 30 units → 85 units; 30 units"]}]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99079","record":[{"status":"Ongoing","city":"Malvern","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99079","recalling_firm":"Siemens Medical Solutions USA, Inc","address_1":"40 Liberty Blvd","address_2":"N/A","postal_code":"19355-1418","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2641-2026","product_description":"ARTIS icono biplane. Model Number: 11327600.","product_quantity":"85 units","reason_for_recall":"Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.","recall_initiation_date":"20260520","center_classification_date":"20260701","report_date":"20260708","code_info":"Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109"},{"status":"Ongoing","city":"Malvern","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99079","recalling_firm":"Siemens Medical Solutions USA, Inc","address_1":"40 Liberty Blvd","address_2":"N/A","postal_code":"19355-1418","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2643-2026","product_description":"ARTIS icono floor. Model Number: 11327700.","product_quantity":"30 units","reason_for_recall":"Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.","recall_initiation_date":"20260520","center_classification_date":"20260701","report_date":"20260708","code_info":"Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067."}]}}