{"recall":{"id":"fda-device-99439","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Maquet Critical Care AB recalls GETINGE Y SENSOR Module","firm":"Maquet Critical Care AB","date":"2026-06-30","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.","code":"DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.","quantity":"9 units","number":"Z-2963-2026","classification":"Class II"}],"reason":"The module did not undergo electrical safety tests and functional tests during production.","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, MN, NY.","nationwide":true,"states":[],"units":"9 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=99439","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"cafbd847903970d0","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=99439","record":[{"status":"Ongoing","city":"Solna","state":"","country":"Sweden","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99439","recalling_firm":"Maquet Critical Care AB","address_1":"Rontgenvagen 2","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, GA, MN, NY.","recall_number":"Z-2963-2026","product_description":"GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.","product_quantity":"9 units","reason_for_recall":"The module did not undergo electrical safety tests and functional tests during production.","recall_initiation_date":"20260630","center_classification_date":"20260814","report_date":"20260826","code_info":"DUI/DI 07325710000304, Serial/Lot Numbers:  21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.","more_code_info":""}]}}