{ "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": 1 } }, "results": [ { "cfres_id": "185804", "product_res_number": "Z-1293-2021", "event_date_initiated": "2021-02-08", "event_date_created": "2021-03-23", "recall_status": "Open, Classified", "res_event_number": "87318", "product_code": "GDC", "product_description": "Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.", "code_info": "S/N (Control unit) - S/N (Operating table): 10290134 - MEC-20195-0034, 10290135 - MEC-20195-0036, 10290136 - MEC-20195-0035, 10290137 - MEC-20195-0033, 10490143 - MEC-20198-0038, 10490144 - MEC-20198-0037, 10490145 - MEC-20198-0040, 10490147 - MEC-20198-0039, 10690148 - MEC-2019Y-0054, 10690149 - MEC-20199-0049, 10690150 - MEC-2019Y-0059, 10690153 - MEC-2019Y-0058, 10690154 - MEC-20199-0046, 10690155 - MEC-2019Y-0057, 10690156 - MEC-20199-0050, 10690157 - MEC-20199-0044, 10690159 - MEC-20199-0047, 10690160 - MEC-20199-0051, 10690161 - MEC-20199-0045, 10690162 - MEC-20199-0048, 10690163 - MEC-2019Y-0053, 10790167 - MEC-2019Y-0052, 10790169 - MEC-2019Y-0056, 10790170 - MEC-2019Y-0055, 211080129 - MEC-2018Z-0029, 11080130 - MEC-2018Z-0028", "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": "Anne LeBlanc\n510-429-1500 Ext. 128", "reason_for_recall": "There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.", "root_cause_description": "Nonconforming Material/Component", "action": "On 2/3/2021 Mizuho sent a \"Recall Notice for Control Unit\" notification letter to affected consignees via Email. In addition to informing consignees about the recall the notification asked consignees to take the following actions: \n\n\n1. Identify if you have the affected product,\n2. Mizuho will replace control units. As soon as we are ready for your institutions, Mizuho will supply the replacements. Please use the auxiliary switch on the operating table until the replacements arrive.", "product_quantity": "26 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.", "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" } } ] }