{"recall":{"id":"fda-device-99520","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Merge Healthcare, Inc. recalls Merge PACS and Merge OrthoPACS","firm":"Merge Healthcare, Inc.","date":"2026-07-22","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation","code":"Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409","quantity":"20 units","number":"Z-3004-2026","classification":"Class II"}],"reason":"Software issue may cause measurements to be displayed inaccurately.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.","nationwide":true,"states":[],"units":"20 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=99520","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4ce950d28fb10644","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=99520","record":[{"status":"Ongoing","city":"Hartland","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99520","recalling_firm":"Merge Healthcare, Inc.","address_1":"900 Walnut Ridge Dr","address_2":"N/A","postal_code":"53029-8347","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 California, Florida, Kentucky, Nebraska, Washington.","recall_number":"Z-3004-2026","product_description":"Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation","product_quantity":"20 units","reason_for_recall":"Software issue may cause measurements to be displayed inaccurately.","recall_initiation_date":"20260722","center_classification_date":"20260821","report_date":"20260902","code_info":"Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409"}]}}