{ "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": "73383", "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": "US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.", "recall_number": "Z-1382-2016", "product_description": "GE Healthcare, Aisys Carestation.", "product_quantity": "1294", "reason_for_recall": "GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.", "recall_initiation_date": "20160217", "center_classification_date": "20160413", "termination_date": "20180904", "report_date": "20160420", "code_info": "ANAS00632 ANAR00333 ANAR00334 ANAR05370 ANAR05371 ANAR05372 TOUCHSCREEN DISPLAY Kits (Each to be instaleed in device. 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