{ "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": "179714", "product_res_number": "Z-0283-2021", "event_date_initiated": "2019-06-17", "event_date_created": "2020-10-23", "recall_status": "Terminated", "event_date_terminated": "2022-07-18", "res_event_number": "84963", "product_code": "NAY", "k_numbers": [ "K131861" ], "product_description": "da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.", "code_info": "IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 101 1266 Kifer Rd", "address_2": "Bldg 101", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "800-876-1310", "reason_for_recall": "One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.", "root_cause_description": "Equipment maintenance", "action": "Send formal customer letter communication to the affected site. The firm reported that a representative scheduled an on-site visit to replace the affected unit.", "product_quantity": "1 system", "distribution_pattern": "US Nationwide distribution including in the state of Washington.", "openfda": { "k_number": [ "K011281", "K242427", "K151794", "K161178", "K183107", "K140553", "K161271", "K101581", "K183224", "K253986", "K192803", "K191482", "K170879", "K251324", "K212747", "K173415", "K173721", "K200049", "K043153", "K241638", "K143132", "K171699", "K040948", "K110639", "K142683", "K170641", "K122532", "K202968", "K252675", "K231798", "K152578", "K230033", "K123840", "K191280", "K050005", "K061260", "K254192", "K211316", "K191529", "K143217", "K222839", "K211325", "K171388", "K242318", "K180351", "K121921", "K171632", "K250442", "K021152", "K123329", "K070947", "K131962", "K021036", "K241284", "K150837", "K202834", "K130726", "K152448", "K162411", "K261824", "K990144", "K173906", "K170645", "K153276", "K243582", "K063220", "K182140", "K011002", "K252350", "K141077", "K210918", "K152421", "K200473", "K241814", "K220023", "K173337", "K040237", "K250786", "K243641", "K232773", "K050369", "K170875", "K172643", "K191736", "K081207", "K162973", "K181517", "K141075", "K042855", "K022574", "K223095", "K251202", "K101743", "K251817", "K120215", "K180163", "K131861", "K123463", "K110451", "K182421", "K251227", "K220889", "K060391", "K082497", "K170713", "K183086", "K050802", "K140189", "K170508", "K043288", "K112208", "K152892", "K233866", "K192877", "K113706", "K012833", "K002489", "K260695", "K081137", "K112263", "K180033", "K203632", "K090993", "K171294", "K211595", "K173585", "K211997", "K182371", "K171947", "K251739", "K252069", "K243714", "K212101", "K202571", "K213710", "K183098", "K190999", "K170644", "K223080", "K240723", "K080291", "K112584", "K170865", "K150284", "K130266", "K211784", "K093217", "K212054", "K253556", "K202166", "K222827", "K171120", "K240502", "K232610", "K250674", "K072627", "K173842", "K231224", "K214095", "K192717", "K171426", "K240852", "K251426", "K030578", "K251213" ], "registration_number": [ "", "3010860245", "3010432890", "2029015", "3015224777", "3001592626", "1226146", "3015336263", "3007029079", "3014309390", "1058584", "3014663814", "2029275", "3007487007", "3009217531", "3017820152", "1531174", "3042940623", "3016607092", "3011390076", "3012811961", "3036035332", "3010684280", "3042953929", "3010157088", "3016096100", "3013868968", "8043903", "3033507886", "3013942591", "3007593944", "3011063460", "3031594238", "3038188839", "3010193531", "3010493171", "2936485", "2011171", "1721686", "3012627460", "2032112", "3003898360", "3004111573", "3009941480", "3038284218", "3012880598", "3039523130", "3015895145", "3016555232", "9611665", "3008309062", "3012453745", "3017636737", "8010877", "3014579024", "3013665681", "3005369776", "9681503", "8010456", "3009719225", "3003537036", "3002259632", "3016832577", "3017119401", "3022626486", "3007111496", "3014635169", "1061124", "1650907", "3038187466", "3009161688", "3014644276", "3007303113", "3008837339", "3013283620", "3013077751", "3013188547", "9614969", "3014656892", "3016079756", "2032098", "3018907196", "2246552", "3018126215", "9616517", "2022435", "3015612252", "3010564249", "3015153469", "3017619652", "3004784537", "3015241782", "3026606306", "3011459762", "3010885402", "2955842", "3001675293", "3020331900" ], "fei_number": [ "", "3010860245", "3010432890", "1000219637", "3015224777", "3001592626", "3015336263", "3007029079", "3014309390", "3014663814", "3007487007", "3009217531", "3017820152", "3042940623", "3002477156", "1000499348", "3016607092", "3011390076", "3012811961", "3036035332", "3010684280", "3042953929", "3010157088", "3016096100", "3013868968", "3033507886", "3013942591", "3007593944", "3011063460", "3031594238", "3942", "3038188839", "3010193531", "3010493171", "2936485", "2011171", "3003076831", "1721686", "3012627460", "3002680121", "3003898360", "1000306431", "3004111573", "3009941480", "3038284218", "3012880598", "3039523130", "3015895145", "3006149253", "3002807095", "3016555232", "3003058448", "3008309062", "3002681132", "3012453745", "3017636737", "3014579024", "3013665681", "1000160458", "3005369776", "3002993297", "3009719225", "3003117688", "3008615487", "3003537036", "3002808088", "3002259632", "3016832577", "3017119401", "1000512168", "3022626486", "3007111496", "3014635169", "3038187466", "3009161688", "3007303113", "3008837339", "3013283620", "3013077751", "3013188547", "3014656892", "3002807793", "3016079756", "3018907196", "2246552", "3018126215", "2022435", "3015612252", "3010564249", "3015153469", "3017619652", "3004784537", "3015241782", "3026606306", "3011459762", "3010885402", "3001675293", "3020331900" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }