{"recall":{"id":"fda-device-99224","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 ARTIS icono ceiling","firm":"Siemens Medical Solutions USA, Inc","date":"2026-06-08","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"ARTIS icono ceiling. Model Number: 11328100.","code":"Model Number: 11328100. UDI-DI: 4056869295923.","quantity":"57 units","number":"Z-2648-2026","classification":"Class II"}],"reason":"Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.","nationwide":true,"states":[],"units":"57 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=99224","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7081d7cb3df1eda9","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=99224","record":[{"status":"Ongoing","city":"Malvern","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99224","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":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.","recall_number":"Z-2648-2026","product_description":"ARTIS icono ceiling. Model Number: 11328100.","product_quantity":"57 units","reason_for_recall":"Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.","recall_initiation_date":"20260608","center_classification_date":"20260701","report_date":"20260708","code_info":"Model Number: 11328100. UDI-DI: 4056869295923."}]}}