{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "53387", "product_res_number": "Z-0079-2008", "event_date_initiated": "2007-03-30", "event_date_posted": "2008-02-21", "recall_status": "Terminated", "event_date_terminated": "2008-09-05", "res_event_number": "38311", "product_code": "NAY", "k_numbers": [ "K050369", "K060322" ], "product_description": "Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.", "code_info": "Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1. System Numbers: all starting with \"SG\"-- 043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170, 098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068, 069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129, 087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169, 041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093, 094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154, 018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012, 015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062, 143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159, 076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and 126", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "950 Kifer Rd", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5206", "additional_info_contact": "408-523-2100", "reason_for_recall": "System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe \"soft-lock\" state.", "root_cause_description": "Software design", "action": "Intuitive Field Service Engineers installed a software upgrade beginning on 03/30/2007, and left a notification letter that the upgrade had been performed at each site. New software level is A5.1 P2.", "product_quantity": "159", "distribution_pattern": "Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.", "openfda": { "k_number": [ "K131861", "K101581", "K113706", "K192803", "K040237", "K120215", "K212747", "K222827", "K130266", "K171632", "K251817", "K022574", "K082497", "K180033", "K112263", "K152892", "K093217", "K150837", "K233866", "K171294", "K173842", "K211325", "K112208", "K182140", "K030578", "K253556", "K202571", "K232610", "K152421", "K241814", "K121921", "K112584", "K043153", "K190999", "K142683", "K211316", "K241638", "K191736", "K110451", "K170865", "K050369", "K152578", "K192877", "K040948", "K170508", "K070947", "K183086", "K240502", "K081207", "K171947", "K242427", "K180351", "K243714", "K214095", "K151794", "K182371", "K202968", "K162973", "K090993", "K181517", "K170879", "K231224", "K143132", "K152448", "K183098", "K243582", "K232773", "K140553", "K230033", "K153276", "K002489", "K081137", "K183107", "K220023", "K192717", "K011002", "K150284", "K042855", "K173337", "K252069", "K061260", "K050802", "K251227", "K241284", "K060391", "K990144", "K043288", "K140189", "K122532", "K123463", "K200049", "K050005", "K141075", "K231798", "K211595", "K011281", "K251213", "K161271", "K210918", "K123840", "K063220", "K251324", "K213710", "K250786", "K260695", "K254192", "K223095", "K250442", "K203632", "K141077", "K173906", "K170641", "K170645", "K171388", "K131962", "K170713", "K170644", "K211784", "K252675", "K212101", "K253986", "K173585", "K202834", "K191482", "K191529", "K251202", "K211997", "K021036", "K143217", "K242318", "K170875", "K161178", "K212054", "K252350", "K012833", "K021152", "K222839", "K220889", "K243641", "K171120", "K202166", "K162411", "K110639", "K173415", "K072627", "K123329", "K251426", "K261824", "K180163", "K080291", "K191280", "K223080", "K101743", "K173721", "K183224", "K200473", "K251739", "K172643", "K182421", "K171426", "K250674", "K240852", "K130726", "K240723", "K171699" ], "registration_number": [ "", "3004111573", "3015241782", "3002259632", "3015895145", "3007029079", "3007487007", "3009217531", "3014579024", "2032098", "3007111496", "3009719225", "3036035332", "3012880598", "3017119401", "3013077751", "2955842", "3017820152", "3013188547", "3001592626", "3010564249", "3017619652", "3014635169", "3012627460", "3016555232", "1531174", "1650907", "2022435", "3014644276", "3018126215", "3014663814", "3009161688", "3010157088", "3010493171", "2029275", "3012453745", "1721686", "3013283620", "3033507886", "3039523130", "3026606306", "3042940623", "3003537036", "3018907196", "3013665681", "1061124", "3042953929", "3010432890", "3016079756", "9681503", "3004784537", "3001675293", "3015224777", "3009941480", "3014656892", "3015612252", "3016832577", "3008309062", "2936485", "2246552", "2029015", "3015336263", "3011063460", "3013942591", "3010860245", "3016607092", "3016096100", "3015153469", "9614969", "1226146", "3008837339", "3005369776", "2011171", "8043903", "8010877", "8010456", "9616517", "3038284218", "3011390076", "3013868968", "3007593944", "3014309390", "3038188839", "3031594238", "3010193531", "3038187466", "9611665", "1058584", "3011459762", "3012811961", "3017636737", "3010885402", "3007303113", "3020331900", "3022626486", "3010684280", "3003898360", "2032112" ], "fei_number": [ "", "3004111573", "3015241782", "3002259632", "3015895145", "3007029079", "3007487007", "3009217531", "3014579024", "3007111496", "3009719225", "3036035332", "3012880598", "3017119401", "3013077751", "1000499348", "3002993297", "3006149253", "3017820152", "3013188547", "3001592626", "3010564249", "3017619652", "3014635169", "3012627460", "3016555232", "3003058448", "3002681132", "3002477156", "2022435", "3018126215", "3008615487", "3014663814", "3009161688", "3010157088", "3010493171", "3012453745", "1721686", "3013283620", "3033507886", "3002807793", "3039523130", "3026606306", "3942", "3042940623", "3003537036", "3018907196", "3013665681", "3042953929", "3010432890", "3016079756", "1000219637", "1000160458", "3004784537", "3001675293", "3015224777", "3009941480", "3014656892", "3015612252", "3016832577", "3008309062", "2936485", "2246552", "3015336263", "1000512168", "3011063460", "3013942591", "3010860245", "3016607092", "3016096100", "3015153469", "3003076831", "3008837339", "3005369776", "2011171", "1000306431", "3002808088", "3002680121", "3038284218", "3011390076", "3013868968", "3007593944", "3014309390", "3038188839", "3031594238", "3010193531", "3038187466", "3002807095", "3011459762", "3012811961", "3017636737", "3010885402", "3007303113", "3020331900", "3003117688", "3022626486", "3010684280", "3003898360" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }