{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "200942", "product_res_number": "Z-2100-2023", "event_date_initiated": "2023-05-19", "event_date_posted": "2023-07-06", "recall_status": "Open, Classified", "res_event_number": "92454", "product_code": "FMZ", "k_numbers": [ "K152814", "K213551" ], "product_description": "Giraffe OmniBed Carestation CS1, \n\nModel Numbers: \na. 2082844-001-XXX, \nb. 2074920-001-XXXXXX, \nc. M1050205, \nd. M1135822, \ne. M1145475, \nf. M1145476, \ng. M1235957, \nh. M1149051, \ni. M1146098;\n\n\n\nLabeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, \nOBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, \nASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make.\n\nIncubator, Neonatal, Warmer, Infant radiant", "code_info": "a. Model Number 2082844-001-XXX; GTIN Numbers: 010084068211686221, 010084068211686221; All Lot/Serial Numbers. \n\nb. Model Number 2074920-001-XXXXXX; No GTIN Number; Serial Numbers: HDGR52137, HDGL50099, HDGT60164, HDGT60143, HDGT60142, HDGT60139, HDGT60138, HDGT60137, HDGU60753, HDGT60652, HDGU60069, HDGT60141, HDGU60156, HDGU60120, HDGU60119, HDGT60163, HDGT60703, HDGT60245, HDGT60160, HDGT60459, HDGT60246, HDGT60235, HDGU67645, HDGU60065, HDGU60063, HDGU60061, HDGU63122, HDGU63121, HDGU60062, HDGU57534, HDGU67533, HDGU67534, HDGT60460, HDGU67236, HDGT60249, HDGU60201, HDGU60570, HDGU60620, HDGU60023, HDGU60020, HDGT60612, HDGU60022, HDGU60571, HDGU60686, HDGU60202, HDGV60190, HDGW60244, HDGU67677, HDGU67676, HDGU67675, HDGU67280, HDGU67416, HDGU67415, HDGU67382, HDGU67377, HDGU67369, HDGU67366, HDGU67362, HDGU67289, HDGU67284, HDGU67282, HDGU63165, HDGU63167, HDGU63166, HDGV61084, HDGU67436, HDGU67423, HDGU67422, HDGU67421, HDGU67420, HDGU67419, HDGU67418, HDGU67414, HDGU67413, HDGU67381, HDGU67380, HDGU67379, HDGU67378, HDGU67370, HDGU67368, HDGU67367, HDGU67365, HDGU67363, HDGU67361, HDGU67360, HDGU67359, HDGU67358, HDGU67357, HDGU67304, HDGU67303, HDGU67302, HDGU67301, HDGU67300, HDGU67299, HDGU67298, HDGU67297, HDGU67296, HDGU67295, HDGU67294, HDGU67293, HDGU67292, HDGU67291, HDGU67290, HDGU67288, HDGU67287, HDGU67286, HDGU67285, HDGU67283, HDGU67281, HDGJ51159, HDGT60613, HDGT60614, HDGU60700, HDGU60703. \n\nc. Model Number M1050205; No GTIN Number; Serial Numbers: HDGV60148, HDGU60656, HDGU60658, HDGT60481, HDGS50047, HDGV60146.\n\nd. Model Number M1135822; No GTIN Number; Serial Numbers: HDGL51737, HDGL51738, HDGL51734, HDGM50736, HDGM50841, HDGL51735.\n\ne. Model Number M1145475; No GTIN Number; Serial Numbers: HDGM51813, HDGM52120, HDGM52119, HDGN50474, HDGN50472, HDGN50471, HDGN50469, HDGN50466, HDGN50464, HDGN50848, HDGN50847, HDGN50846, HDGN50845, HDGN50844, HDGQ50049, HDGR53203, HDGS51654, HDGS51653, HDGS51652, HDGS51651, HDGS51650, HDGS51649, HDGS51648, HDGS51647, HDGS51646, HDGS51645, HDGM51179, HDGQ50425, HDGN50465, HDGN50849, HDGN50467, HDGN50470, HDGN50475, HDGR52324, HDGR52323, HDGR52322, HDGR52321, HDGN50468.\n\nf. Model Number M1145476; No GTIN Number; Serial Numbers: HDGR52896. \n\ng. Model Number M1235957; No GTIN Number; Serial Numbers: HDGT60222. \n\nh. Model Number M1149051; No GTIN Number; Serial Numbers: HDGR53018, HDGR53085, HDGR52927, HDGR53086, HDGR53021. \n\ni. Model Number M1146098; No GTIN Number; Serial Numbers: HDGS52233, HDGS52234.", "firm_fei_number": "3014220748", "recalling_firm": "DATEX--OHMEDA, INC.", "address_1": "9900 W Innovation Dr", "city": "Wauwatosa", "state": "WI", "postal_code": "53226-4856", "additional_info_contact": "GE Healthcare Service\n800-437-1171", "reason_for_recall": "GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices", "root_cause_description": "Nonconforming Material/Component", "action": "GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees beginning on 05/19/2023 by mail. The notice explained the problem, risk, and requeested the following: \nActions to be taken by Customer/User: \nInspect the device bedside panels; if the device has the correct latches, continue to use the device. If the device does not have the correct latches, quarantine the device. Inspect any field replaceable bedside panel stock and quarantine for the affected product. \nGE Healthcare will replace affected latches.", "product_quantity": "4,540 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K001242", "K072512", "K922618", "K870223", "K840526", "K040910", "K821896", "K993407", "K870222", "K810792", "K101788", "K901585", "K152809", "K924297", "K890476", "K243437", "K182859", "K914864", "K172154", "K031387", "K020547", "K781876", "K900735", "K913154", "K915752", "K912909", "K954204", "K071977", "K960980", "K010222", "K884086", "K260326", "K895550", "K912910", "K920049", "K913291", "K021809", "K251619", "K802640", "K871399", "K943360", "K132543", "K101778", "K822656", "K071175", "K802639", "K070291", "K213553", "K901157", "K003067", "K912000", "K061856", "K974349", "K802126", "K040068", "K190494", "K053399", "K903378", "K924170", "K810067", "K914134", "K801461", "K980886", "K813238", "K940975", "K813239", "K061280", "K900752", "K913394", "K020543", "K102710", "K993051", "K881476", "K152814", "K162821", "K924324", "K993712", "K780472", "K251663", "K182977", "K962806", "K895782", "K914487", "K832418", "K102279", "K102226" ], "registration_number": [ "3007734888", "9613793", "3008729547", "3036470679", "3014220748", "3009077524", "1034876", "9710602", "3006179052", "3005934741", "1043214", "9611500", "3049808762", "3030089838", "3030733800", "2510954", "1000122786", "3005652389", "1066270", "1226711", "1054241", "3021559257", "1055236", "1054713", "3012348048" ], "fei_number": [ "1000112877", "3007734888", "3008729547", "3006469671", "3001104093", "3036470679", "3014220748", "3009077524", "1034876", "3006179052", "3003513129", "3005934741", "1043214", "1000112968", "3049808762", "3030089838", "3030733800", "3003338236", "2510954", "1000122786", "1000114111", "3021559257", "3004846435", "3012348048", "3000957797" ], "device_name": "Incubator, Neonatal", "medical_specialty_description": "General Hospital", "regulation_number": "880.5400", "device_class": "2" } } ] }