{ "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": "167866", "product_res_number": "Z-0479-2019", "event_date_initiated": "2018-09-25", "event_date_created": "2018-11-19", "recall_status": "Terminated", "event_date_terminated": "2020-07-13", "res_event_number": "81224", "product_code": "FMZ", "k_numbers": [ "K152814" ], "product_description": "Giraffe OmniBed Carestation. Neonatal incubator. 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2082844-001-526493, 010084068211686221TABW6398711171213 (TABW63987); 2082844-001-526493, 010084068211686221TABX6214111180119 (TABX62141); 2082844-001-526493, 010084068211686221TABW6409911171219 (TABW64099); 2082844-001-526493, 010084068211686221TABW6400911171213 (TABW64009); 2082844-001-526493, 010084068211686221TABW6396611171211 (TABW63966); 2082844-001-526493, 010084068211686221TABW6400811171213 (TABW64008); 2082844-001-526493, 010084068211686221TABX6215411180122 (TABX62154); 2082844-001-526493, 010084068211686221TABW6408611171219 (TABW64086); 2082844-001-526493, 010084068211686221TABX6210811180117 (TABX62108); 2082844-001-526493, 010084068211686221TABX6213011180119 (TABX62130); 2082844-001-526493, 010084068211686221TABW6406911171219 (TABW64069); 2082844-001-526493, 010084068211686221TABW6408411171219 (TABW64084); 2082844-001-526493, 010084068211686221TABW6404311171218 (TABW64043); 2082844-001-526493, 010084068211686221TABW6409811171219 (TABW64098); 2082844-001-526493, 010084068211686221TABW6396411171211 (TABW63964); 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 2082844-001-526493, 010084068211686221TABX6222711180130 (TABX62227);  2082844-001-526493, 010084068211686221TABX6216811180123 (TABX62168);  2082844-001-526493, 010084068211686221TABX6216411180123 (TABX62164);  2082844-001-526493, 010084068211686221TABX6214911180122 (TABX62149);  2082844-001-526493, 010084068211686221TABX6217811180123 (TABX62178);  2082844-001-526493, 010084068211686221TABX6220611180129 (TABX62206);  2082844-001-526493, 010084068211686221TABX6216511180123 (TABX62165);  2082844-001-526493, 010084068211686221TABX6225011180201 (TABX62250);  2082844-001-526493, 010084068211686221TABX6217311180123 (TABX62173);  2082844-001-526493, 010084068211686221TABX6216211180123 (TABX62162);  2082844-001-526493, 010084068211686221TABX6216611180123 (TABX62166);  2082844-001-526493, 010084068211686221TABX6223411180130 (TABX62234);  2082844-001-526493, 010084068211686221TABX6220811180129 (TABX62208);  2082844-001-526493, 010084068211686221TABW6395211171211 (TABW63952);  2082844-001-526493, 010084068211686221TABW6395111171211 (TABW63951);  2082844-001-526493, 010084068211686221TABW6407811171219 (TABW64078);  2082844-001-526493, 010084068211686221TABX6211011180117 (TABX62110);  2082844-001-526493, 010084068211686221TABX6211311180117 (TABX62113);  2082844-001-526493, 010084068211686221TABX6233211180207 (TABX62332);  2082844-001-526493, 010084068211686221TABX6228211180201 (TABX62282);  2082844-001-526493, 010084068211686221TABX6228311180201 (TABX62283);  2082844-001-526493, 010084068211686221TABW6404611171218 (TABW64046);  2082844-001-526493, 010084068211686221TABW6400011171213 (TABW64000);  2082844-001-526493, 010084068211686221TABW6409511171219 (TABW64095);  2082844-001-526493, 010084068211686221TABW6409611171219 (TABW64096);  2082844-001-526493, 010084068211686221TABW6393311171211 (TABW63933);  2082844-001-526493, 010084068211686221TABX6232411180207 (TABX62324);  2082844-001-526493, 010084068211686221TABX6229211180202 (TABX62292);  2082844-001-526493, 010084068211686221TABX6225411180201 (TABX62254);  2082844-001-526493, 010084068211686221TABX6225511180201 (TABX62255);  2082844-001-526493, 010084068211686221TABX6225811180201 (TABX62258);  2082844-001-487119, Not Applicable (TABV60433);  2082844-001-526493, 010084068211686221TABX6219711180124 (TABX62197);  2082844-001-526493, 010084068211686221TABX6212811180119 (TABX62128);  2082844-001-526493, 010084068211686221TABW6394411171211 (TABW63944);  2082844-001-526493, 010084068211686221TABW6398211171213 (TABW63982);  2082844-001-526493, 010084068211686221TABW6394811171211 (TABW63948);  2082844-001-526493, 010084068211686221TABW6394011171211 (TABW63940);  2082844-001-526493, 010084068211686221TABX6222611180130 (TABX62226);  2082844-001-526493, 010084068211686221TABW6393711171211 (TABW63937);  2082844-001-526493, 010084068211686221TABX6224011180130 (TABX62240);  2082844-001-526493, 010084068211686221TABX6223911180130 (TABX62239);  2082844-001-526493, 010084068211686221TABW6399611171213 (TABW63996);  2082844-001-526493, 010084068211686221TABX6224311180130 (TABX62243);  2082844-001-526493, 010084068211686221TABX6224211180130 (TABX62242);  2082844-001-526493, 010084068211686221TABX6224411180201 (TABX62244);  2082844-001-526493, 010084068211686221TABX6222911180130 (TABX62229);  2082844-001-526769, 010084068211686221TABW6397711171212 (TABW63977);  2082844-001-526493, 010084068211686221TABW6401311171213 (TABW64013);  2082844-001-526493, 010084068211686221TABW6395911171211 (TABW63959);  2082844-001-526493, 010084068211686221TABW6408211171219 (TABW64082);  2082844-001-526493, 010084068211686221TABW6402311171213 (TABW64023);  2082844-001-526493, 010084068211686221TABW6396511171211 (TABW63965);  2082844-001-526493, 010084068211686221TABX6233511180207 (TABX62335);  2082844-001-526493, 010084068211686221TABX6229511180202 (TABX62295);  2082844-001-526493, 010084068211686221TABX6224611180201 (TABX62246);  2082844-001-526493, 010084068211686221TABX6225311180201 (TABX62253);  2082844-001-526493, 010084068211686221TABX6222311180130 (TABX62223);  2082844-001-526493, 010084068211686221TABX6225111180201 (TABX62251);  2082844-001-526493, 010084068211686221TABX6225211180201 (TABX62252); 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 2082844-001-526493, 010084068211686221TABX6213211180119 (TABX62132);  2082844-001-526493, 010084068211686221TABX6217111180123 (TABX62171);  2082844-001-526493, 010084068211686221TABX6221811180130 (TABX62218);  2082844-001-526493, 010084068211686221TABW6405911171219 (TABW64059);  2082844-001-526493, 010084068211686221TABX6224711180201 (TABX62247);  2082844-001-526493, 010084068211686221TABX6223111180130 (TABX62231);  2082844-001-403566, Not Applicable (TABU67011);  2082844-001-499499, 010084068211686221TABW6259811170606 (TABW62598);  2082844-001-430326, Not Applicable (TABV60027);  2082844-001-430326, Not Applicable (TABV60030);  2082844-001-430326, Not Applicable (TABV60028);  2082844-001-430326, Not Applicable (TABU67004);  2082844-001-462725, Not Applicable (TABU67040);  2082844-001-462725, Not Applicable (TABU67039);  2082844-001-462725, Not Applicable (TABU67056);  2082844-001-462725, Not Applicable (TABU67041);  2082844-001-462725, Not Applicable (TABU67053);  2082844-001-462725, Not Applicable (TABU67045);  2082844-001-462725, Not Applicable (TABU67047);  2082844-001-462725, Not Applicable (TABU67050);  2082844-001-462725, Not Applicable (TABU67043);  2082844-001-460023, Not Applicable (TABU67014);  2082844-001-510290, 010084068211685521TABV61236160902 (TABV61236);  2082844-001-558377, 010084068211686221TABX6238011180219 (TABX62380);  2082844-001-534467, 010084068211686221TABX6330711180628 (TABX63307);  2082844-001-534467, 010084068211686221TABX6330611180628 (TABX63306);  2082844-001-534467, 010084068211686221TABX6331411180628 (TABX63314);  2082844-001-534467, 010084068211686221TABX6236011180213 (TABX62360);  2082844-001-534467, 010084068211686221TABX6331211180628 (TABX63312);  2082844-001-534467, 010084068211686221TABX6331111180628 (TABX63311);  2082844-001-534467, 010084068211686221TABX6330911180628 (TABX63309);  2082844-001-534467, 010084068211686221TABX6331511180628 (TABX63315);  2082844-001-501649, 010084068211686221TABX6330411180626 (TABX63304);  2082844-001-501649, 010084068211686221TABX6330311180626 (TABX63303);  2082844-001-501649, 010084068211686221TABX6330511180626 (TABX63305);  2082844-001-467192, Not Applicable (TABV60033);  2082844-001-495642, Not Applicable (TABV60053);  2082844-001-508846, 010084068211686221TABX6247711180301 (TABX62477);  2082844-001-508846, 010084068211686221TABX6247611180301 (TABX62476);  2082844-001-508846, 010084068211686221TABX6246211180228 (TABX62462);  2082844-001-508846, 010084068211686221TABX6246311180228 (TABX62463);  2082844-001-508846, 010084068211686221TABX6248411180305 (TABX62484);  2082844-001-508846, 010084068211686221TABX6248511180305 (TABX62485);  2082844-001-498552, 010084068211686221TABX6248911180305 (TABX62489);  2082844-001-498552, 010084068211686221TABX6248611180305 (TABX62486);  2082844-001-498552, 010084068211686221TABX6248711180305 (TABX62487);  2082844-001-498552, 010084068211686221TABX6248811180305 (TABX62488);  2082844-001-508846, 010084068211686221TABX6332211180629 (TABX63322);  2082844-001-508846, 010084068211686221TABX6332111180629 (TABX63321);  2082844-001-508846, 010084068211686221TABX6221111180130 (TABX62211);  2082844-001-508846, 010084068211686221TABX6221211180130 (TABX62212);  2082844-001-485099, Not Applicable (TABV60013);  2082844-001-485099, Not Applicable (TABV60102);  2082844-001-485099, Not Applicable (TABV60055);  2082844-001-485099, Not Applicable (TABV60054);  2082844-001-485099, Not Applicable (TABV60065);  2082844-001-485099, Not Applicable (TABV60015);  2082844-001-485099, Not Applicable (TABV60072);  2082844-001-485099, Not Applicable (TABV60069);  2082844-001-485099, Not Applicable (TABV60016);  2082844-001-512022, 010084068211686221TABX6332411180702 (TABX63324);  2082844-001-531627, 010084068211686221TABX6254211180309 (TABX62542);  2082844-001-512022, 010084068211686221TABX6254111180307 (TABX62541);  2082844-001-495786, Not Applicable (TABV60056);  2082844-001-565598, 010084068211686221TABX63177180605 (TABX63177);  2082844-001-565598, 010084068211686221TABX63176180605 (TABX63176);  2082844-001-565598, 010084068211686221TABX63175180605 (TABX63175);  2082844-001-535110, 010084068211686221TABX6332011180629 (TABX63320);  2082844-001-534358, 010084068211686221TABX6237111180215 (TABX62371);  2082844-001-534358, 010084068211686221TABX6266511180313 (TABX62665);  2082844-001-523533, 010084068211686221TABW62153170215 (TABW62153);  2082844-001-547388, 010084068211686221TABX63316180628 (TABX63316);  2082844-001-498396, 010084068211686221TABX6331811180629 (TABX63318);  2082844-001-498396, 010084068211686221TABX6331911180629 (TABX63319);  2082844-001-505050, 010084068211686221TABX62459180227 (TABX62459);  2082844-001-505050, 010084068211686221TABX62460180227 (TABX62460);  2082844-001-505050, 010084068211686221TABW63210170815 (TABW63210);  2082844-001-507094, 010084068211685521TABV61052160804 (TABV61052);  2082844-001-510416, 010084068211686221TABX62540180307 (TABX62540);  2082844-001-500909, 010084068211686221TABX62457180227 (TABX62457);  2082844-001-500909, 010084068211686221TABX62458180227 (TABX62458);  2082844-001-477964, Not Applicable (TABU67058);  2082844-001-516038, 010084068211686221TABX6246111180227 (TABX62461);  2082844-001-501478, 010084068211686221TABX62431180222 (TABX62431);  2082844-001-471681, Not Applicable (TABU67028);  2082844-001-471681, Not Applicable (TABU67034);  2082844-001-471681, Not Applicable (TABU67032);  2082844-001-462005, Not Applicable (TABU67021);  2082844-001-462005, Not Applicable (TABU67026);  2082844-001-516778, 010084068211686221TABX6248011180302 (TABX62480);  2082844-001-516778, 010084068211686221TABX6248111180302 (TABX62481);  2082844-001-516778, 010084068211686221TABX6247811180302 (TABX62478);  2082844-001-516778, 010084068211686221TABX6247911180302 (TABX62479);  2082844-001-516778, 010084068211686221TABV6231611161114 (TABV62316);  2082844-001-500008, 010084068211686221TABX62365180215 (TABX62365);  2082844-001-500008, 010084068211686221TABX62363180215 (TABX62363);  2082844-001-500008, 010084068211686221TABX62362180215 (TABX62362);  2082844-001-500008, 010084068211686221TABX62367180215 (TABX62367);  2082844-001-500008, 010084068211686221TABX62364180215 (TABX62364);  2082844-001-500008, 010084068211686221TABX62366180215 (TABX62366);  2082844-001-500008, 010084068211686221TABX62369180215 (TABX62369);  2082844-001-500008, 010084068211686221TABX62368180215 (TABX62368);  2082844-001-500008, 010084068211685521TABV62289161114 (TABV62289);  2082844-001-500008, 010084068211685521TABV62294161114 (TABV62294);  2082844-001-499372, 010084068211686221TABX62377180215 (TABX62377);  2082844-001-499372, 010084068211686221TABX62376180215 (TABX62376);  2082844-001-499372, 010084068211686221TABX62373180215 (TABX62373);  2082844-001-499372, 010084068211686221TABX62374180215 (TABX62374);  2082844-001-517864, 010084068211686221TABX63236180619 (TABX63236);  2082844-001-517864, 010084068211686221TABX63252180619 (TABX63252);  2082844-001-403565, Not Applicable (TABV60039);  2082844-001-559202, 010084068211686221TABX6248211180302 (TABX62482);  2082844-001-403565, Not Applicable (TABV60097);  2082844-001-403565, Not Applicable (TABV60062);  2082844-001-403565, Not Applicable (TABV60003);  2082844-001-403565, Not Applicable (TABV60060);", "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": "800-437-1171", "reason_for_recall": "Potential electric leakage affecting the user.", "root_cause_description": "Process design", "action": "GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. \n\nFor questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "1,724 devices total", "distribution_pattern": "Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.", "openfda": { "k_number": [ "K914864", "K900735", "K801461", "K182859", "K903378", "K993051", "K021809", "K901585", "K924324", "K924297", "K813238", "K072512", "K780472", "K810792", "K962806", "K102226", "K913154", "K890476", "K900752", "K802640", "K101788", "K162821", "K980886", "K901157", "K020543", "K172154", "K924170", "K102710", "K810067", "K213553", "K922618", "K010222", "K101778", "K071977", "K913394", "K914487", "K020547", "K821896", "K182977", "K912909", "K954204", "K040910", "K822656", "K895550", "K001242", "K132543", "K040068", "K102279", "K915752", "K031387", "K152809", "K871399", "K802126", "K243437", "K993712", "K003067", "K190494", "K895782", "K152814", "K914134", "K840526", "K940975", "K061280", "K993407", "K061856", "K870223", "K912910", "K781876", "K251663", "K813239", "K913291", "K802639", "K974349", "K870222", "K832418", "K912000", "K881476", "K053399", "K943360", "K070291", "K260326", "K884086", "K071175", "K920049", "K251619", "K960980" ], "device_name": "Incubator, Neonatal", "medical_specialty_description": "General Hospital", "regulation_number": "880.5400", "device_class": "2", "registration_number": [ "", "3012348048", "1055236", "3014220748", "1000122786", "3001104093", "3005934741", "9710602", "3005652389", "9613793", "1043214", "3021559257", "2510954", "3008729547", "1066270", "3006179052", "3007734888", "1226711", "3036470679", "1054241", "3009077524", "9611500", "3030089838", "1054713", "1034876" ], "fei_number": [ "", "1000114111", "3012348048", "3023530182", "1000112877", "3014220748", "1000122786", "3001104093", "3005934741", "3004846435", "1043214", "3021559257", "1000112968", "3006469671", "2510954", "3008729547", "3006179052", "3003513129", "3007734888", "3036470679", "3009077524", "3000957797", "3030089838", "1034876", "3003338236" ] } } ] }