{"recall":{"id":"fda-device-99637","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 Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04","firm":"GE Medical Systems Information Technologies Inc","date":"2026-07-30","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV","code":"5867474-04 UDI-DI 00195278343512 Device Serial Numbers begin with STU 5867474-13 UDI-DI 00195278516367 Device Serial Numbers begin with STU 5867474-03 UDI-DI 00195278343383 Device Serial Numbers begin with STV","quantity":"29,570 (23,632 US; 5,938 OUS)","number":"Z-3143-2026","classification":"Class II"}],"reason":"Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution.","nationwide":true,"states":[],"units":"29,570 (23,632 US; 5,938 OUS)","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=99637","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8ffe9290ca235178","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=99637","record":[{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99637","recalling_firm":"GE Medical Systems Information Technologies Inc","address_1":"3114 N Grandview Blvd","address_2":"N/A","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-3143-2026","product_description":"Carescape Central Station    CSCS V3 MAS800 Desktop  Part Number 5867474-04, 5867474-13  Product code STU    CSCS V3 MAI800  Integrated   Part Number 5867474-03  Product Code STV","product_quantity":"29,570 (23,632 US; 5,938 OUS)","reason_for_recall":"Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.","recall_initiation_date":"20260730","center_classification_date":"20260911","report_date":"20260923","code_info":"5867474-04 UDI-DI 00195278343512 Device Serial Numbers begin with STU  5867474-13 UDI-DI 00195278516367 Device Serial Numbers begin with STU  5867474-03 UDI-DI 00195278343383 Device Serial Numbers begin with STV","more_code_info":""}]}}