{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "178322", "product_res_number": "Z-0813-2020", "event_date_initiated": "2019-11-25", "event_date_posted": "2020-01-23", "recall_status": "Terminated", "event_date_terminated": "2023-11-30", "res_event_number": "84438", "product_code": "BSZ", "k_numbers": [ "K151570" ], "product_description": "Carestation 620/650/650c A1\n\nProduct Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.", "code_info": "CARESTATION 620 A1, Model Number 1012-9620-000\nMfg. 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650 A1, Model Number 1012-9650-000\nMfg. Lot or Serial #\tUDI 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8470050WA11181122\nSM718470051WA\t010084068210394721SM718470051WA11181122\nSM718470052WA\t010084068210394721SM718470052WA11181122\nSM718470053WA\t010084068210394721SM718470053WA11181122\nSM719020028MA\t010084068210394721SM719020028MA11190110\nSM718460018MA\t010084068210394721SM718460018MA11181112\nSM718460019MA\t010084068210394721SM718460019MA11181112\nSM718460020MA\t010084068210394721SM718460020MA11181112\nSM718390035MA\t010084068210394721SM718390035MA11180924\nSM718390042MA\t010084068210394721SM718390042MA11180926\nSM718390043MA\t010084068210394721SM718390043MA11180926\nSM718390044MA\t010084068210394721SM718390044MA11180926\nSM718390045MA\t010084068210394721SM718390045MA11180926\nSM718390046MA\t010084068210394721SM718390046MA11180926\nSM718390047MA\t010084068210394721SM718390047MA11180926\nSM718390048MA\t010084068210394721SM718390048MA11180926\nSM718390049MA\t010084068210394721SM718390049MA11180926\nSM718390050MA\t010084068210394721SM718390050MA11180926\nSM719150045MA\t010084068210394721SM719150045MA11190409\nSM719070038MA\t010084068210394721SM719070038MA11190213\nSM718040037MA\t010084068210394721SM718040037MA11180123\n\nCARESTATION 650C A1, Model Number 1012-9655-000\nMfg. Lot or Serial #\tUDI #\nSM818430002MA\t010084068210395421SM818430002MA11181023\nSM818430004MA\t010084068210395421SM818430004MA11181023\nSM818430006MA\t010084068210395421SM818430006MA11181023\nSM818430001MA\t010084068210395421SM818430001MA11181023\nSM818430003MA\t010084068210395421SM818430003MA11181023\nSM818430005MA\t010084068210395421SM818430005MA11181023\nSM819190001MA\t010084068210395421SM819190001MA11190509\nSM819190002MA\t010084068210395421SM819190002MA11190509\nSM819190003MA\t010084068210395421SM819190003MA11190509\nSM819190004MA\t010084068210395421SM819190004MA11190509\nSM819190005MA\t010084068210395421SM819190005MA11190509\nSM819190006MA\t010084068210395421SM819190006MA11190509\nSM819100001MA\t010084068210395421SM819100001MA11190304\nSM819100002MA\t010084068210395421SM819100002MA11190304\nSM819060001MA\t010084068210395421SM819060001MA11190205\nSM818360001WA\t010084068210395421SM818360001WA11180903\nSM819050001WA\t010084068210395421SM819050001WA11190131\nSM819050002WA\t010084068210395421SM819050002WA11190131\nSM819230001WA\t010084068210395421SM819230001WA11190604\nSM819230002WA\t010084068210395421SM819230002WA11190604\nSM819040001WA\t010084068210395421SM819040001WA11190123\nSM819080001WA\t010084068210395421SM819080001WA11190221\nSM819080002WA\t010084068210395421SM819080002WA11190221\nSM819080003WA\t010084068210395421SM819080003WA11190221\nSM819080004WA\t010084068210395421SM819080004WA11190221\nSM819170001WA\t010084068210395421SM819170001WA11190425\nSM819020001WA\t010084068210395421SM819020001WA11190110\nSM819020002WA\t010084068210395421SM819020002WA11190110\nSM819020003WA\t010084068210395421SM819020003WA11190110\nSM819020004WA\t010084068210395421SM819020004WA11190110\nSM819020005WA\t010084068210395421SM819020005WA11190110\nSM819020011WA\t010084068210395421SM819020011WA11190111\nSM819140014WA\t010084068210395421SM819140014WA11190403\nSM819140015WA\t010084068210395421SM819140015WA11190403\nSM819230003WA\t010084068210395421SM819230003WA11190606\nSM819140016MA\t010084068210395421SM819140016MA11190403\nSM819140017MA\t010084068210395421SM819140017MA11190403\nSM819140018MA\t010084068210395421SM819140018MA11190403\nSM819140019MA\t010084068210395421SM819140019MA11190403\nSM819140020MA\t010084068210395421SM819140020MA11190403\nSM819140021MA\t010084068210395421SM819140021MA11190403\nSM819140022MA\t010084068210395421SM819140022MA11190403\nSM819140023MA\t010084068210395421SM819140023MA11190403\nSM819140024MA\t010084068210395421SM819140024MA11190403\nSM819140025MA\t010084068210395421SM819140025MA11190403\nSM819140026MA\t010084068210395421SM819140026MA11190403\nSM819140027MA\t010084068210395421SM819140027MA11190403\nSM819140028MA\t010084068210395421SM819140028MA11190403", "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 Heathcare Service\n800-437-1171", "reason_for_recall": "GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.", "root_cause_description": "Process control", "action": "The firm initiated their field notification by letter on November 25, 2019. The letter states the reason for recall and provides the following safety instructions:\nYou can continue to use the anesthesia system.\n - If you observe the message Ventilate Manually! , change from mechanical to manual ventilation. At any time, the clinician may use a self-inflating bag to ventilate the patient and/or switch to another anesthesia device. Contact your GE Healthcare representative for repair of the device.\n - Perform the planned maintenance (PM) every 12-months at a minimum per the User s Reference Manual which includes inspection of the cable connection. Note: This inspection step is included in the annual PM described in the Technical Reference Manual. Performing this step in the PM would confirm the integrity of the cable connection.\n\nContact Information: If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. \n\nThe firm will be correcting the units.\nThe firm issued a Press Release on January 13, 2020.", "product_quantity": "3319 units", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of: Albania, Algeria, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia and Hrvatska, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.", "openfda": { "k_number": [ "K802591", "K791530", "K112722", "K923172", "K213867", "K981530", "K030939", "K930351", "K850648", "K010613", "K072420", "K151570", "K781492", "K884802", "K071142", "K050055", "K003663", "K132530", "K884879", "K090892", "K864644", "K801100", "K971425", "K131790", "K041430", "K062155", "K072884", "K890410", "K102389", "K083413", "K170872", "K000859", "K102471", "K801103", "K900328", "K855022", "K133958", "K844849", "K872178", "K972848", "K905635", "K771479", "K011404", "K061102", "K001727", "K925580", "K982137", "K042154", "K882489", "K041622", "K000706", "K862085", "K930492", "K830159", "K833147", "K800801", "K003251", "K081844", "K230931", "K980553", "K840356", "K201957", "K060193", "K030624", "K050883", "K971030", "K853435", "K050676", "K131945", "K900937", "K864806", "K801102", "K854213", "K790456", "K973949", "K862831", "K965041", "K963481", "K071097", "K771989", "K945722", "K822218", "K852175", "K875350", "K120075", "K171292", "K945234", "K833335", "K073707", "K101439", "K033498", "K103035", "K191027", "K081447", "K920944", "K973971", "K853139", "K973985", "K894309", "K251352", "K992421", "K760228", "K861170", "K963994", "K830161", "K946127", "K051629", "K001988", "K143530", "K844563", "K012446", "K171311", "K901117", "K133886", "K123125", "K080175", "K903991", "K140264", "K864589", "K081941", "K841274", "K900329", "K122063", "K983635", "K921742", "K031400", "K935546", "K042086", "K901119", "K974193", "K934669", "K122445", "K001488", "K040743", "K803052", "K844421", "K902962", "K003579", "K863207", "K052335", "K970163", "K933285", "K923519", "K771057", "K172045", "K042419", "K062388", "K841370", "K132903", "K903135", "K893780", "K102182", "K112114", "K945463", "K830160", "K001315", "K110213", "K032803", "K864447", "K973896", "K160665", "K965160", "K830680", "K113633", "K090233", "K844012", "K913791", "K083098", "K092864", "K142552", "K993410", "K151954", "K123211", "K033026", "K901713", "K981845", "K022031", "K050626", "K844008", "K864590", "K061609", "K833151", "K770554", "K884991", "K000995", "K252746", "K851621", "K042607", "K253330" ], "registration_number": [ "", "3009156722", "3007238566", "9610531", "1066270", "9611500", "3005783425", "3013188547", "9611295", "3000126629", "3001104093", "2518157", "1000122786", "3003589956", "8043316", "3007603826", "3035111606", "3005803793", "2112667", "3022543477", "2020813", "9617604", "1066427", "3014579161", "8010042", "3010157426", "3009129579", "1530958", "3021559257", "2221819", "9710602", "3016618143", "3010703925", "1054713" ], "fei_number": [ "", "3009156722", "3007238566", "3003513129", "3000957797", "1000114111", "3005783425", "3013188547", "3003319165", "3000126629", "3023530182", "3001104093", "2518157", "1000122786", "3002807907", "3003589956", "3002807992", "3007603826", "3007513035", "3002558692", "3035111606", "3005803793", "2112667", "3022543477", "2020813", "3002808128", "3014579161", "3010157426", "3009129579", "3021559257", "2221819", "1000639866", "3016618143", "3010703925" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }