{"url_path":"/fda/device/recalls/Z-2963-2026","section_key":"summary","section_title":"DEVICE Recall: Maquet Critical Care AB — 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.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-30","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2963-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Maquet Critical Care AB"},"word_count":99,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2963-2026\n\n**Recalling firm:** Maquet Critical Care AB\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-30\n**Report date:** 2026-08-26\n\n## Product\nGETINGE 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.\n\n## Reason\nThe module did not undergo electrical safety tests and functional tests during production.\n\n## Affected lots\nDUI/DI 07325710000304, Serial/Lot Numbers:  21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.\n\n## Distribution\nUS Nationwide distribution in the states of CA, GA, MN, NY."}