{ "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": "175629", "product_res_number": "Z-0281-2020", "event_date_initiated": "2019-07-26", "event_date_created": "2019-11-04", "recall_status": "Open, Classified", "res_event_number": "83532", "product_code": "FMZ", "k_numbers": [ "K152814" ], "product_description": "Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.", "code_info": "Model Number: 2082844-001;   Serial Number (UDI Number): TABY70690 (010084068211686221TABY7069011190610), TABY70692 (010084068211686221TABY7069211190611), TABY70708 (010084068211686221TABY7070811190612), TABY70719 (010084068211686221TABY7071911190613), TABY70709 (010084068211686221TABY7070911190612), TABY70724 (010084068211686221TABY7072411190614), TABY70722 (010084068211686221TABY7072211190614), TABY70718 (010084068211686221TABY7064211190603), TABY70717 (010084068211686221TABY7064411190603), TABY70712 (010084068211686221TABY7064511190603), TABY70678 (010084068211686221TABY7067811190607), TABY70725 (010084068211686221TABY7072511190615), TABY70672 (010084068211686221TABY7067211190607), TABY70686 (010084068211686221TABY7068611190610), TABY70688 (010084068211686221TABY7068811190610), TABY70697 (010084068211686221TABY7069711190611), TABY70726 (010084068211686221TABY7072611190616), TABY70729 (010084068211686221TABY7072911190616), TABY70645 (010084068211686221TABY7064711190604), TABY70647 (010084068211686221TABY7066011190605), TABY70646 (010084068211686221TABY7071211190613), TABY70644 (010084068211686221TABY7071711190613), TABY70642 (010084068211686221TABY7071811190613), TABY70732 (010084068211686221TABY7073211190617), TABY70723 (010084068211686221TABY7072311190614), TABY70747 (010084068211686221TABY7074711190619), TABY70748 (010084068211686221TABY7074811190619), TABY70673 (010084068211686221TABY7067311190607), TABY70676 (010084068211686221TABY7067611190607), TABY70693 (010084068211686221TABY7069311190611), TABY70648 (010084068211686221TABY7064811190604), TABY70675 (010084068211686221TABY7067511190607), TABY70694 (010084068211686221TABY7069411190611), TABY70695 (010084068211686221TABY7069511190611), TABY70730 (010084068211686221TABY7073011190617), TABY70734 (010084068211686221TABY7073411190617), TABY70737 (010084068211686221TABY7073711190618), TABY70677 (010084068211686221TABY7067711190607), TABY70698 (010084068211686221TABY7069811190611), TABY70699 (010084068211686221TABY7069911190611), TABY70703 (010084068211686221TABY7070311190612), TABY70706 (010084068211686221TABY7070611190612), TABY70727 (010084068211686221TABY7072711190616), TABY70728 (010084068211686221TABY7072811190616), TABY70660 (010084068211686221TABY7064611190603), TABY70689 (010084068211686221TABY7068911190610), TABY70705 (010084068211686221TABY7070511190612), TABY70707 (010084068211686221TABY7070711190612), TABY70731 (010084068211686221TABY7073111190617), TABY70733 (010084068211686221TABY7073311190617), TABY70652 (Not Available),  TABY70654 (Not Available), TABY70662 (Not Available), TABY70664 (Not Available), TABY70710 (Not Available), TABY70715 (Not Available), TABY70716 (Not Available), TABY70753 (Not Available), TABY70659 (Not Available), TABY70704 (010084068211686221TABY7070411190612),  TABY70755 (010084068211686221TABY7075511190620), TABY70638 (Not Available), TABY70649 (Not Available), TABY70656 (Not Available), TABY70661 (Not Available), TABY70657 (Not Available), TABY70650 (Not Available), TABY70667 (Not Available), TABY70668 (Not Available), TABY70653 (Not Available), TABY70663 (Not Available), TABY70670 (Not Available), TABY70665 (Not Available), TABY70669 (Not Available), TABY70671 (Not Available), TABY70714 (Not Available), TABY70658 (Not Available), TABY70655 (Not Available), TABY70666 (Not Available), TABY70651 (Not Available).", "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": "Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.", "root_cause_description": "Nonconforming Material/Component", "action": "GE Healthcare notified customers on about 07/26/2019 via phone calls and a \"URGENT MEDICAL DEVICE CORRECTION\" letter. Customers were instructed to immediately stop use of and segregate the affected devices, that GE Healthcare would correct all affected products at no cost, and a GE Healthcare representative will contact them to arrange for the correction. \n\nQuestions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative. \n\nA second customer letter was sent on 08/05/2019 to all customer. The second letter contained the same instructions, but provided an updated list of affected serial numbers.", "product_quantity": "59 devices (50 US, 9 OUS)", "distribution_pattern": "Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA. \n\nCountries of China, France, Germany, Korea, Republic of China.", "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" ] } } ] }