{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203513", "product_res_number": "Z-0170-2024", "event_date_initiated": "2023-09-15", "event_date_posted": "2023-10-30", "recall_status": "Terminated", "event_date_terminated": "2024-09-26", "res_event_number": "93129", "product_code": "NAY", "k_numbers": [ "K223095" ], "product_description": "Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system", "code_info": "UDI/DI 00815440022075, Serial Numbers: SN 00012, SN 00016, SN 00007, SN 00017, SN 00035, SN 00018, SN 00042, SN 00008, SN 00031, SN 00025, SN 00011, SN 00028, SN 00038, SN 00029, SN 00036, SN 00025, SN 00024, SN 00006, SN 00019, SN 00040, SN 00041, loaded with Software (SW) version 2.7.4", "firm_fei_number": "3007593944", "recalling_firm": "Asensus Surgical Inc", "address_1": "1 Tw Alexander Dr Ste 160 1 Tw Alexander Dr", "address_2": "Ste 160", "city": "Durham", "state": "NC", "postal_code": "27709", "additional_info_contact": "Ravi Kommineni\n763-227-5896 Ext. 140", "reason_for_recall": "Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.", "root_cause_description": "Software design", "action": "Asensus Surgical issued an URGENT MEDICAL DEVICE RECALL to its consignees on 09/15/2023 by mail. The notice explained the problem, risk to health, and requested users to cease use of the device until software version 2.7.5 is installed.", "product_quantity": "21 units", "distribution_pattern": "US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania", "openfda": { "k_number": [ "K152892", "K252350", "K122532", "K211997", "K254192", "K120215", "K171120", "K171947", "K223080", "K251817", "K140189", "K233866", "K123840", "K170875", "K253986", "K242318", "K240502", "K042855", "K170713", "K191280", "K123329", "K230033", "K093217", "K121921", "K173842", "K990144", "K131962", "K210918", "K231798", "K211595", "K182140", "K241814", "K214095", "K002489", "K253556", "K171632", "K161271", "K170508", "K080291", "K220889", "K240723", "K170641", "K182371", "K181517", "K242427", "K232610", "K251227", "K151794", "K153276", "K211325", "K171388", "K170644", "K170879", "K241638", "K072627", "K040948", "K251426", "K213710", "K192803", "K022574", "K180163", "K101743", "K243714", "K192717", "K011002", "K012833", "K021036", "K101581", "K250674", "K212054", "K113706", "K171699", "K150837", "K243641", "K240852", "K172643", "K131861", "K202968", "K252069", "K192877", "K231224", "K212747", "K040237", "K021152", "K081207", "K143217", "K191482", "K170865", "K243582", "K200473", "K173415", "K173721", "K182421", "K222839", "K180351", "K183107", "K260695", "K112584", "K030578", "K203632", "K251739", "K223095", "K110639", "K043153", "K232773", "K171294", "K050005", "K202834", "K063220", "K110451", "K123463", "K180033", "K252675", "K152421", "K162411", "K060391", "K190999", "K250786", "K261824", "K191529", "K050369", "K082497", "K250442", "K170645", "K162973", "K202166", "K141077", "K112208", "K241284", "K141075", "K251202", "K173585", "K161178", "K081137", "K183086", "K061260", "K112263", "K143132", "K140553", "K173906", "K211316", "K222827", "K152448", "K251213", "K152578", "K142683", "K212101", "K050802", "K090993", "K171426", "K183224", "K130726", "K011281", "K211784", "K220023", "K173337", "K183098", "K070947", "K191736", "K150284", "K251324", "K130266", "K043288", "K202571", "K200049" ], "registration_number": [ "3003898360", "", "8043903", "9681503", "3011459762", "3038284218", "3013188547", "3014656892", "3009941480", "2032112", "3010684280", "3015895145", "3011063460", "3007487007", "3010157088", "2936485", "3018907196", "3036035332", "1531174", "2029015", "3022626486", "3014644276", "3012627460", "3016555232", "3009719225", "3016832577", "3014663814", "8010877", "3010193531", "3014635169", "3013077751", "3004111573", "3012880598", "2032098", "1650907", "2011171", "1061124", "3016607092", "3015336263", "3008837339", "9614969", "3018126215", "3042953929", "3010564249", "1721686", "3005369776", "2022435", "3013942591", "2955842", "3020331900", "3009161688", "3017636737", "3009217531", "3011390076", "1058584", "3017820152", "3001675293", "8010456", "3017119401", "3014309390", "3012811961", "3013283620", "3010432890", "3015153469", "3003537036", "3014579024", "3001592626", "3026606306", "3010885402", "3010860245", "3015224777", "3038188839", "3015612252", "3004784537", "9616517", "2246552", "3007303113", "3008309062", "3039523130", "3038187466", "3033507886", "3007111496", "3017619652", "2029275", "3016096100", "3016079756", "3042940623", "3012453745", "3013868968", "3010493171", "3002259632", "1226146", "3013665681", "9611665", "3031594238", "3007593944", "3015241782", "3007029079" ], "fei_number": [ "3003898360", "", "1000219637", "3003076831", "1000160458", "3011459762", "3038284218", "3003117688", "3013188547", "3014656892", "3009941480", "3010684280", "3015895145", "1000306431", "3011063460", "3007487007", "3010157088", "2936485", "3018907196", "3036035332", "3022626486", "3002477156", "3012627460", "3002807095", "3016555232", "3009719225", "3016832577", "3014663814", "3010193531", "3002808088", "3014635169", "3013077751", "3004111573", "3012880598", "3002993297", "2011171", "3016607092", "3015336263", "3008837339", "3018126215", "3042953929", "3010564249", "3002807793", "1721686", "3005369776", "2022435", "3013942591", "3020331900", "3009161688", "3006149253", "3017636737", "3009217531", "3011390076", "3017820152", "3001675293", "3017119401", "3014309390", "3012811961", "3013283620", "3010432890", "3015153469", "3002681132", "3003537036", "3014579024", "3001592626", "3026606306", "3010885402", "3010860245", "3015224777", "3008615487", "3038188839", "3015612252", "3004784537", "1000512168", "2246552", "3007303113", "3008309062", "3039523130", "3038187466", "3033507886", "3007111496", "3017619652", "3003058448", "3016096100", "3016079756", "3042940623", "3012453745", "3013868968", "3010493171", "3942", "3002259632", "3013665681", "3002680121", "1000499348", "3031594238", "3007593944", "3015241782", "3007029079" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }