{"recall":{"id":"fda-device-99475","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"GE Medical Systems Information Technologies Inc recalls GE Healthcare Portrait Core Services SW V 1","firm":"GE Medical Systems Information Technologies Inc","date":"2026-07-10","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system","code":"GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.","quantity":"11 units","number":"Z-2878-2026","classification":"Class II"}],"reason":"A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.","nationwide":true,"states":[],"units":"11 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=99475","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7a2fe7908ccee29d","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=99475","record":[{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99475","recalling_firm":"GE Medical Systems Information Technologies Inc","address_1":"3114 N Grandview Blvd","address_2":"","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.","recall_number":"Z-2878-2026","product_description":"GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system","product_quantity":"11 units","reason_for_recall":"A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).","recall_initiation_date":"20260710","center_classification_date":"20260804","report_date":"20260812","code_info":"GTIN 00198953056752, Lot/Serial Numbers:  SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.","more_code_info":""}]}}