{"recall":{"id":"fda-device-99529","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"FUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7","firm":"FUJIFILM Healthcare Americas Corporation","date":"2026-07-22","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"FUJIFILM Synapse PACS software v7.4.310; radiological image processing system","code":"UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38","quantity":"6 units","number":"Z-3030-2026","classification":"Class II"}],"reason":"Software issue may cause the ruler measurement to be inaccurate.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.","nationwide":true,"states":[],"units":"6 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=99529","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"9c318399d0a881af","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=99529","record":[{"status":"Ongoing","city":"Lexington","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99529","recalling_firm":"FUJIFILM Healthcare Americas Corporation","address_1":"81 Hartwell Ave Ste 300","address_2":"N/A","postal_code":"02421-3160","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.","recall_number":"Z-3030-2026","product_description":"FUJIFILM Synapse PACS software v7.4.310; radiological  image processing system","product_quantity":"6 units","reason_for_recall":"Software issue may cause the ruler measurement to be inaccurate.","recall_initiation_date":"20260722","center_classification_date":"20260826","report_date":"20260902","code_info":"UDI (01)00854904006008(10)0704310, Serial Numbers:  CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38"}]}}