{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Waukesha", "state": "WI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "72943", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "address_2": "N/A", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.", "recall_number": "Z-0677-2016", "product_description": "GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.", "product_quantity": "1081", "reason_for_recall": "The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.", "recall_initiation_date": "20151215", "center_classification_date": "20160121", "termination_date": "20160921", "report_date": "20160127", "code_info": "AESPIRE 7900 ANCU00662 ANCU00813 ANCU00814 ANCU00815 ANCU00816 ANCU00817 ANCU00818 ANCU00597 ANCU00598 ANCU00599 ANCU00600 ANCU00601 ANCU00671 ANCU00672 ANCU00673 ANCU00676 ANCU00678 ANCU00683 ANCU00830 ANCU00832 ANCU00870 ANCU00871 ANCU00872 ANCU00873 ANCU00874 ANCU00875 ANCU00629 ANCU00630 ANCU00638 ANCU00639 ANCU00640 ANCU00641 ANCU00806 ANCU00604 ANCU00684 ANCU00836 ANCU00837 ANCU00839 ANCU00786 ANCU00680 ANCU00681 ANCU00625 ANCU00626 ANCU00677 ANCU00618 ANCU00619 ANCU00620 ANCU00602 ANCU00603 ANCU00448 ANCU00449 ANCU00770 ANCU00771 ANCU00865 ANCU00866 ANCU00867 ANCU00803 ANCU00605 ANCU00663 ANCU00682 ANCU00685 ANCU00458 ANCU00459 ANCU00831 ANCU00653 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