{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "180895", "product_res_number": "Z-0566-2021", "event_date_initiated": "2019-09-11", "event_date_created": "2020-12-14", "recall_status": "Open, Classified", "res_event_number": "85442", "product_code": "GDC", "product_description": "Microsurgical Operating Room Tables;7300B (18-350-70);", "code_info": "MUC-20168-0001, MUC-20168-0002, MUC-20171-0003, MUC-20171-0004, MUC-20173-0005, MUC-20173-0006, MUC-20178-0007 & MUC-20178-0008", "firm_fei_number": "1000159388", "recalling_firm": "Mizuho America, Inc.", "address_1": "30057 Ahern Ave", "city": "Union City", "state": "CA", "postal_code": "94587-1234", "additional_info_contact": "510-324-4500 Ext. 150", "reason_for_recall": "Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.", "root_cause_description": "Device Design", "action": "The firm's representatives notified their U.S. consignees regarding the recall notification by phone and a separate FedEx letter was sent (08/09/2019 - date the letter was issued).\n\nThe Customer Notification Letter \"IMPORTANT VOLUNTARY RECALL NOTIFICATION\", informed customers of the two (2) types of errors:\n1) Unintended Tilting of the Tabletop - Impurities in the hydraulic oil has caused minor leaking inside a control valve causing the table to tilt after remaining static for long periods of time.\n2) Incorrect Operation due to Infrared Operating Signal Errors - The table can inadvertently mix infrared signals from the hand pendant while using in the wireless mode and may cause unintended movement.\n\nCustomer are also being informed that a sales representative will contact them to organize the logistics of the correction for the tables.\n\nThe recall notification includes to visit the firm's webpage (www.mizuho.com) to find additional information related to the recall. For additional questions, the Customer Service Group or local sales representatives can be contacted.", "product_quantity": "8", "distribution_pattern": "US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI.\nOUS: Greece, Israel, Japan, and Ukraine.", "openfda": { "k_number": [ "K970807", "K851021", "K853720", "K821749", "K851829", "K850168", "K821665", "K914758", "K964273", "K934744", "K851830", "K843134", "K853535", "K883613", "K853480", "K971390", "K940616", "K915393" ], "registration_number": [ "", "9680579", "3033433849", "3003574554", "3010890274", "3030558088", "3029970239", "9610617", "3030681105", "2020550", "3015286905", "3011537487", "3015515531", "3005083075", "3015223105", "3008610343", "3010326005", "1043572", "3006063136", "3006975482", "9611102", "9611503", "3042991836", "8030607", "3005607354", "3009129579", "3006223081", "9680168", "3030194752", "3042992004", "3043177791", "3010202439", "3007417753", "3021839632", "3020703842", "2182536", "3009567010", "3005843419", "3030516433", "3035678069", "3042970964", "3015376465", "3034669683", "3014342096", "2916714", "3014680784", "1412854", "3010373494", "2247992", "3012010520", "3017884063", "3009610508", "9613910", "3015468226", "3002532594", "3008388379", "3003851947", "3012165496", "9680242", "3010446656", "1648279", "3027520367", "3003749961", "1824206", "8021896", "3003898943", "1643264", "3021559257", "3043654660", "3009715914", "3013836619", "3027847726", "1836161", "3031700059", "3006142326", "9681454", "3037012186", "3003604053", "3007278668", "1066635", "3003696170", "1825014", "3011659880", "3012708860", "3007123908", "3007238566", "3011647337", "3006897996", "3017181414", "1066270", "3011547624", "3025628903", "3031582440", "3015131225", "9710385", "3011574775", "1000122786", "3016590299", "3007143268", "3008881803", "3010594257", "3013774640", "1066427", "3003900596", "8010153", "3006697241", "3011580044", "1717548", "2031963", "3010373263", "3014302716", "3013846070", "3023449169", "3009212453", "3043178571" ], "fei_number": [ "", "3033433849", "3002750084", "3003574554", "1000203464", "3001168737", "3010890274", "3030558088", "3029970239", "3030681105", "2020550", "3015286905", "3011537487", "1000516389", "3015515531", "3015223105", "3008610343", "3010326005", "3005083075", "1043572", "3006063136", "3006975482", "3007513035", "3007475226", "3042991836", "3005607354", "3009129579", "3006223081", "3030194752", "3042992004", "3043177791", "3007417753", "3006509795", "3020703842", "2182536", "3009567010", "3005843419", "1000125341", "3030516433", "3035678069", "3009504761", "3042970964", "3015376465", "3034669683", "3014342096", "2916714", "3003184737", "1412854", "3010373494", "3012010520", "3017884063", "3009610508", "3002808001", "1000208827", "3000957797", "3015468226", "3002532594", "3008388379", "3002975342", "3012165496", "3003851947", "3010446656", "3003138129", "3027520367", "3003749961", "3002572935", "1824206", "3003898943", "1643264", "3021559257", "1825560", "3043654660", "3009715914", "3013836619", "3002808335", "3006125657", "3027847726", "3031700059", "3002808268", "3006142326", "3037012186", "3003604053", "3007278668", "3003696170", "1825014", "3011659880", "3012708860", "3007123908", "3007238566", "3011647337", "3006897996", "3017181414", "3011547624", "3025628903", "3031582440", "1000295034", "3015131225", "3004574120", "3011574775", "1000122786", "3016590299", "3007143268", "3008881803", "3010594257", "3013774640", "3003900596", "3006697241", "3011580044", "1717548", "3010373263", "3014302716", "3013846070", "3023449169", "3009212453", "3043178571" ], "device_name": "Table, Operating-Room, Electrical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1" } } ] }