{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "217544", "product_res_number": "Z-0913-2026", "event_date_initiated": "2025-11-14", "event_date_posted": "2025-12-18", "recall_status": "Open, Classified", "res_event_number": "98064", "product_code": "BSZ", "k_numbers": [ "K151570" ], "product_description": "GE Healthcare Carestation anesthesia system, product number and REF numbers: \nCarestation 610 A1, REF 1012-9620-222; \nCarestation 620 A1 REF 1012-9620-000; \nCarestation 620 A1, REF 1012-9620-200; \nCarestation 620 A1, REF 1012-9620-202; \nCarestation 620 SE A1, REF 1012-9620-212; \nCarestation 630 A1, REF 1012-9650-222; \nCarestation 650 A1, REF 1012-9650-000; \nCarestation 650 A1, REF 1012-9650-200; \nCarestation 650 A1, REF 1012-9650-202; \nCarestation 650 SE A1, REF 1012-9650-212; \nCarestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine\n\nProducts for which affected PMB can be used as a spare part: \nCarestation 620 A2, REF 1012-9620-002 00840682124546\nCarestation 620 SE A2, REF 1012-9620-012 00195278569677\nCarestation 650 A2, REF 1012-9650-002 00840682124560\nCarestation 650 SE A2, REF 1012-9650-012 00195278569684\nCarestation 650c A1, REF 1012-9655-000 00840682103954\nCarestation 650c A2, REF 1012-9655-002 00840682124539\nCarestation 650c A1, REF 1012-9655-200 00195278439543", "code_info": "REF 1012-9620-222: GTIN 00195278626301; \nREF 1012-9620-000: GTIN 00840682103985; \nREF 1012-9620-200: GTIN 00195278439536; \nREF 1012-9620-202: GTIN 00195278626158; \nREF 1012-9620-212: GTIN 00195278626561; \nREF 1012-9650-222: GTIN 00195278626592; \nREF 1012-9650-000: GTIN 00840682103947; \nREF 1012-9650-200: GTIN 00195278439529; \nREF 1012-9650-202: GTIN 00195278626585; \nREF 1012-9650-212: GTIN 00195278625687; \nREF 1012-9655-202: GTIN 00195278625953; \nREF 1012-9620-002: GTIN 00840682124546; \nREF 1012-9620-012: GTIN 00195278569677; \nREF 1012-9650-002: GTIN 00840682124560; \nREF 1012-9650-012: GTIN 00195278569684; \nREF 1012-9655-000: GTIN 00840682103954; \nREF 1012-9655-002: GTIN 00840682124539; \nREF 1012-9655-200: GTIN 00195278439543.", "firm_fei_number": "3003513129", "recalling_firm": "GE Medical Systems China Co., Ltd.", "address_1": "Dev. Zone National Hi-Tech No. 19 Changjiang Road", "city": "Wuxi", "state": "XIN", "country": "China", "additional_info_contact": "GE HealthCare Service\n800-437-1171", "reason_for_recall": "Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. \nAnesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.", "root_cause_description": "Component change control", "action": "GE Healthcare issued an \"URGENT MEDICAL DEVICE CORRECTION\" notice to its consignees on 11/14/2025 via letter using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken by Customer/User: \n\"Pending correction by GE HealthCare, you can continue to use the Anesthesia\nmachine with affected power management boards by following the instructions below:\n1. Always ensure the device has a secure connection to an AC mains power source. \n2. If there is a loss of AC mains power to the system leading to an unexpected system shutdown: \n - Promptly initiate ventilation using a self-inflating bag connected to an oxygen source. \n - Assess oxygenation via pulse oximetry. \n - Because volatile anesthetic agent delivery may transiently be disrupted, supplement with or transition to intravenous anesthetics as needed.\n - Following system reboot, the system will enter pre-use check. Press \"Start Anesthesia or Start Case and then select the \"Bypass\" button to bypass the checkout. Proceed to selecting the ventilation parameters and volatile agent concentration appropriate for the\npatient. \nPlease ensure all potential users in your facility are made aware of this safety notification and the recommended actions. \nPlease retain this document for your records. \nPlease complete and return the attached acknowledgement form to\nRECALL.FMI34143@gehealthcare.com or submit the acknowledgment using survey.\" \n\nFor questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "1277 units", "distribution_pattern": "Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.", "openfda": { "k_number": [ "K071097", "K172045", "K120075", "K103035", "K864447", "K142552", "K965160", "K973949", "K841274", "K830160", "K072420", "K090233", "K011404", "K123211", "K060193", "K062388", "K901117", "K900328", "K833147", "K875350", "K133958", "K123125", "K800801", "K131945", "K830159", "K050676", "K132903", "K112722", "K191027", "K791530", "K933285", "K112114", "K052335", "K151954", "K252746", "K833151", "K903135", "K801102", "K050626", "K862831", "K862085", "K923519", "K935546", "K981530", "K802591", "K050883", "K902962", "K032803", "K945463", "K090892", "K000995", "K132530", "K890410", "K041622", "K972848", "K974193", "K853139", "K992421", "K853435", "K000859", "K822218", "K864806", "K101439", "K033498", "K946127", "K031400", "K963994", "K844563", "K864590", "K864644", "K133886", "K801100", "K001988", "K081844", "K844421", "K012446", "K041430", "K840356", "K900937", "K771057", "K803052", "K003663", "K850648", "K963481", "K042419", "K071142", "K042086", "K863207", "K852175", "K945722", "K113633", "K140264", "K844849", "K903991", "K901119", "K925580", "K171311", "K001488", "K083413", "K770554", "K251352", "K930492", "K934669", "K042607", "K901713", "K855022", "K980553", "K080175", "K965041", "K884879", "K872178", "K893780", "K073707", "K050055", "K040743", "K000706", "K083098", "K854213", "K010613", "K971425", "K945234", "K982137", "K844012", "K771479", "K973971", "K170872", "K131790", "K003579", "K033026", "K900329", "K801103", "K973985", "K030939", "K051629", "K841370", "K151570", "K781492", "K983635", "K081447", "K993410", "K981845", "K030624", "K844008", "K923172", "K930351", "K003251", "K122445", "K864589", "K970163", "K171292", "K160665", "K905635", "K230931", "K973896", "K894309", "K790456", "K830680", "K920944", "K062155", "K110213", "K061609", "K884802", "K913791", "K072884", "K102389", "K022031", "K833335", "K143530", "K201957", "K081941", "K760228", "K882489", "K884991", "K102471", "K102182", "K061102", "K861170", "K042154", "K771989", "K213867", "K830161", "K122063", "K971030", "K253330", "K001727", "K851621", "K001315", "K092864", "K921742" ], "registration_number": [ "", "1530958", "1000122786", "3003589956", "3035111606", "9610531", "8010042", "3007238566", "3010157426", "9617604", "1054713", "3022543477", "8043316", "3001104093", "3009129579", "3007603826", "3013188547", "2112667", "3005783425", "3005803793", "9611500", "2020813", "3000126629", "3009156722", "3016618143", "3010703925", "3014579161", "9611295", "2518157", "9710602", "2221819", "1066427", "1066270", "3021559257" ], "fei_number": [ "3007513035", "", "3002807992", "1000122786", "3003589956", "3035111606", "3007238566", "1000114111", "3010157426", "3022543477", "3023530182", "3001104093", "3009129579", "3007603826", "3013188547", "3003319165", "2112667", "3005783425", "3003513129", "3005803793", "2020813", "1000639866", "3000126629", "3009156722", "3016618143", "3010703925", "3002808128", "3014579161", "2518157", "3000957797", "2221819", "3002807907", "3002558692", "3021559257" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }