{ "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": "142535", "product_res_number": "Z-0792-2016", "event_date_initiated": "2015-12-14", "event_date_posted": "2016-02-09", "recall_status": "Terminated", "event_date_terminated": "2016-02-10", "res_event_number": "72937", "product_code": "GDC", "product_description": "Mizuho OSI Trios, Table Base;\nVoltage: 100-240V ~ 50/60 Hz\nAmps: 5,0-5.0A;\nModel 7803 and 7803AP\n\nOrthopaedic:\nOperating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.", "code_info": "Model numbers 7803, 7803AP.  Serial numbers 228-261.", "firm_fei_number": "2921578", "recalling_firm": "Mizuho OSI", "address_1": "30031 Ahern Ave", "city": "Union City", "state": "CA", "postal_code": "94587-1234", "additional_info_contact": "Bill Bregar\n800-777-4674 Ext. 166", "reason_for_recall": "Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.", "root_cause_description": "Employee error", "action": "All consignees were notified by telephone and a recall letter was mailed to each facility as a follow up. Customers were asked to remove tables from operation until they were inspected by OSI service personnel.", "product_quantity": "33", "distribution_pattern": "US, South Africa, Japan and United Arab Emirates.", "openfda": { "k_number": [ "K970807", "K821749", "K843134", "K851829", "K971390", "K934744", "K821665", "K883613", "K853535", "K915393", "K940616", "K850168", "K914758", "K851830", "K853480", "K851021", "K964273", "K853720" ], "registration_number": [ "", "1066270", "3010326005", "3011547624", "3009567010", "2182536", "3015131225", "1824206", "3017181414", "3002532594", "3015468226", "3043178571", "3043654660", "3010373494", "3025628903", "3009129579", "3020703842", "3029970239", "9611503", "3009212453", "1825014", "3005843419", "3015286905", "3011659880", "3009610508", "3003900596", "3014680784", "3010202439", "1717548", "9680579", "3011647337", "3016590299", "3017884063", "3005083075", "9680168", "3015223105", "3021839632", "3010594257", "3003696170", "3012165496", "3008881803", "3007123908", "3027847726", "1066427", "3003574554", "9681454", "3035678069", "3021559257", "3013836619", "9680242", "8021896", "3007417753", "3015515531", "1043572", "2247992", "3007238566", "3042991836", "9610617", "8010153", "3003749961", "3013846070", "3010373263", "3008388379", "3006063136", "3011580044", "3012708860", "3006697241", "3030558088", "1000122786", "3006142326", "3007143268", "3003604053", "3030194752", "3011537487", "1412854", "2031963", "2916714", "3034669683", "3009715914", "3042992004", "3007278668", "3013774640", "9611102", "3033433849", "9613910", "3031700059", "3043177791", "3006897996", "3010446656", "3031582440", "3042970964", "3023449169", "3015376465", "3008610343", "9710385", "3006223081", "3003898943", "3030681105", "1836161", "2020550", "3011574775", "3014342096", "1648279", "8030607", "3014302716", "1066635", "3006975482", "3003851947", "3030516433", "3005607354", "3037012186", "1643264", "3010890274" ], "fei_number": [ "", "3010326005", "3011547624", "3009567010", "2182536", "3015131225", "1824206", "3017181414", "3002532594", "3002808268", "3015468226", "1825560", "3001168737", "3043178571", "3043654660", "3010373494", "3025628903", "3002750084", "3009129579", "3020703842", "3029970239", "3007475226", "3009212453", "1825014", "3005843419", "3015286905", "3011659880", "3009610508", "3003900596", "3002808335", "1717548", "3011647337", "3016590299", "3007513035", "3017884063", "3005083075", "3015223105", "3010594257", "3003696170", "1000516389", "3012165496", "3008881803", "3007123908", "3003184737", "3027847726", "3004574120", "1000208827", "3003574554", "3035678069", "3021559257", "3013836619", "3007417753", "3015515531", "3006125657", "1043572", "3007238566", "3042991836", "1000295034", "3003749961", "3013846070", "3010373263", "3008388379", "3006063136", "3011580044", "3012708860", "3006697241", "3030558088", "1000122786", "3006142326", "3007143268", "3003604053", "3030194752", "3011537487", "1412854", "2916714", "3034669683", "3009715914", "3042992004", "3007278668", "3013774640", "3002572935", "3033433849", "3031700059", "3002808001", "3002975342", "3043177791", "3006897996", "3003138129", "3010446656", "3031582440", "3042970964", "3009504761", "3023449169", "3015376465", "3000957797", "3008610343", "3006223081", "3003898943", "3030681105", "3006509795", "1000203464", "1000125341", "2020550", "3011574775", "3014342096", "3014302716", "3006975482", "3003851947", "3030516433", "3005607354", "3037012186", "1643264", "3010890274" ], "device_name": "Table, Operating-Room, Electrical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1" } } ] }