{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211403", "product_res_number": "Z-0816-2025", "event_date_initiated": "2024-11-18", "event_date_posted": "2025-01-07", "recall_status": "Open, Classified", "res_event_number": "95855", "product_code": "CAD", "k_numbers": [ "K172702" ], "product_description": "Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV", "code_info": "GTIN: 00840682124720;\nSerial Numbers: 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QBD01560\nSQBD01582\nSQBC03648\nSQBC03840\nSQBC03878\nSQBC03935\nSQBD00683\nSQBD00689\nSQBD00709\nSQBD00715\nSQBC01709\nSQBD02634\nSQBC05402\nSQBC05405\nSQBC05409\nSQBC05428\nSQBC05516\nSQBD01286\nSQBD01418", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "reason_for_recall": "Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.", "root_cause_description": "Process control", "action": "An URGENT MEDICAL DEVICE CORRECTION notification letter dated 11/18/24 was sent to customers.\n\nActions to be taken by Customer/User\nYou can continue to use the vaporizer in accordance with the instructions in the User Reference Manual (URM) and the actions described below:\n1. Perform the Output Concentration Check described in Appendix 1 for every impacted vaporizer (see Affected Product Details in this letter).\n\" If a vaporizer passes the Output Concentration Check, you can continue to use that vaporizer. GE HealthCare recommends use of anesthetic agent monitoring during vaporizer use.\n\" If a vaporizer fails the Output Concentration Check, you can continue to use that vaporizer with anesthetic agent monitoring until GE HealthCare corrects the vaporizer.\n\" If a vaporizer fails the Output Concentration Check and anesthetic agent monitoring is not available, remove the vaporizer from service.\n2. Please complete and return the attached Medical Device Notification Acknowledgement Response Form to ARC.FMI34139@gehealthcare.com\n3. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions.\n4. Please retain this document for your records.\n\nIf you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "928 units", "distribution_pattern": "US Nationwide. Global Distribution.", "openfda": { "k_number": [ "K945993", "K942799", "K012924", "K821650", "K923265", "K981472", "K980884", "K872053", "K031027", "K002878", "K954801", "K810289", "K884686", "K000275", "K960944", "K990132", "K942055", "K771899", "K761160", "K971923", "K864605", "K980489", "K240375", "K771150", "K882500", "K961468", "K821966", "K953748", "K844007", "K771892", "K942091", "K150167", "K860545", "K041076", "K892057", "K002343", "K051666", "K053564", "K973051", "K843993", "K841157", "K913593", "K952083", "K770021", "K981773", "K936046", "K060331", "K790359", "K042276", "K854202", "K110608", "K172702", "K861839", "K831427", "K942545", "K760668", "K884090" ], "registration_number": [ "", "3007603826", "3009156722", "9611500", "3009116370", "1320909", "9610531", "2221819", "2112667", "3014579161", "2022648", "9611295", "3001104093", "8022032" ], "fei_number": [ "", "3007603826", "3009156722", "3002807992", "3009116370", "2221819", "3002807907", "3023530182", "2112667", "3001717360", "3014579161", "2022648", "1000135935", "3001104093" ], "device_name": "Vaporizer, Anesthesia, Non-Heated", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5880", "device_class": "2" } } ] }