{ "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": "177043", "product_res_number": "Z-0760-2020", "event_date_initiated": "2019-09-27", "event_date_posted": "2020-01-10", "recall_status": "Terminated", "event_date_terminated": "2023-09-26", "res_event_number": "84034", "product_code": "CCK", "k_numbers": [ "K133576" ], "product_description": "Airway Gas Option N-CAiO", "code_info": "Mfg. Lot or Serial #\tUDI # SGV19268009HA\t010084068210407421SGV19268009HA11190626 SGV19248001HA\t010084068210407421SGV19248001HA11190611 SGV19258009HA\t010084068210407421SGV19258009HA11190618 SGV19248004HA\t010084068210407421SGV19248004HA11190611 SGV19258006HA\t010084068210407421SGV19258006HA11190618 SGV19258003HA\t010084068210407421SGV19258003HA11190618 SGV19258005HA\t010084068210407421SGV19258005HA11190618 SGV19258012HA\t010084068210407421SGV19258012HA11190618 SGV19258020HA\t010084068210407421SGV19258020HA11190618 SGV19268003HA\t010084068210407421SGV19268003HA11190626 SGV19268004HA\t010084068210407421SGV19268004HA11190626 SGV19268005HA\t010084068210407421SGV19268005HA11190626", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE Healthcare Service\n800-437-1171", "reason_for_recall": "Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.", "root_cause_description": "Process control", "action": "The firm issued the Urgent Medical Device Correction Letter dated 09/27/2019. The letter describes the failure and requests replacement of the affected module with another module. If a replacement is not available, the consignee is directed to follow the instructions below to ensure that your respiratory module O2 reading is within specifications (a) before any new patient case is started and (b) for prolonged patient cases, at a minimum of once a day: \n1) Connect the module to the host device;\n2) Ensure the module is fully warmed up by having it powered on for minimum 20 minutes;\n3) Configure the O2 reading and waveform to the host device screen as defined in the host device instructions;\n4) Feed 100% O2 gas flow from the ventilator to the module and observe the O2 reading and waveform; and\n5) Ensure the O2 reading is within specifications 100% +/-3% and there is no erratic behavior in the waveform.\n6) If you are unable to complete the above steps successfully, remove the respiratory module from clinical use and quarantine. \n\nContact GE Healthcare Service or your local Service Representative.\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": "12 units", "distribution_pattern": "US\nOUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom", "openfda": { "k_number": [ "K915494", "K910509", "K213518", "K810927", "K843599", "K832005", "K083056", "K983864", "K863640", "K874754", "K150272", "K941982", "K213911", "K823049", "K792155", "K203762", "K874036", "K942567", "K140473", "K000712", "K920622", "K040847", "K892406", "K890112", "K181467", "K920915", "K112840", "K941971", "K103604", "K063813", "K881093", "K964239", "K894429", "K833397", "K870858", 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