{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198067", "product_res_number": "Z-1262-2023", "event_date_initiated": "2023-01-24", "event_date_posted": "2023-03-16", "recall_status": "Open, Classified", "res_event_number": "91505", "product_code": "NAY", "k_numbers": [ "K131861", "K171294" ], "product_description": "Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200;\n\nPatient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000", "code_info": "System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers:\nIS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, \nIS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962", "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": "Alex Mathews\n408-523-2100", "reason_for_recall": "Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.", "root_cause_description": "Component change control", "action": "On 01/24/2023, New Field Safety Notices were sent to customers. In addition, some customers received another notice informing them that additional preventative maintenance data would need to be collected by the recalling firm's field service personnel, to determine if additional devices were affected. On 1/27/2023, updated New Field Safety Notices were sent to two additional customers. Customers were asked to do the following:\n1) Review this Field Safety Notification with all system users and place a copy of it with Instructions for use (IFU) of the system. \n2) Complete and return the Acknowledgment Form via email to Recalls@intusurg.com\n\nThe recalling firm will replace instrument arms found to be affected and will update the Preventive Maintenance Test to include the same analysis/method of processing Insertion Axis Friction Data that was used for determining the affected product for this Field Safety Notice so any new USM that may become susceptible will get addressed as part of the same.\n\nCustomers with questions can contact customer service at:\n- US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.\n- Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com\n- South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com\n- Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com\nTaiwan: 886-2-2-27008181 (9am to 6:00pm CST) or CS.taiwan@intusurg.com", "product_quantity": "9", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France", "openfda": { "k_number": [ "K011002", "K150837", "K250674", "K180163", "K252675", "K260695", "K022574", "K090993", "K131962", "K202571", "K200049", "K192717", "K173721", "K070947", "K232610", "K173585", "K170875", "K191736", "K063220", "K183086", "K222839", "K162411", "K241284", "K233866", "K990144", "K130266", "K251227", "K171947", "K213710", "K243714", "K170644", "K231224", "K170645", "K170865", "K101581", "K214095", "K030578", "K251213", "K210918", "K061260", "K151794", "K241814", "K211595", "K050369", "K251739", "K021036", "K254192", "K143132", "K171426", "K012833", "K093217", "K171294", "K183107", "K252069", "K211997", "K152578", "K253556", "K220023", "K191482", "K021152", "K180033", "K211784", "K251817", "K152421", "K170641", "K141075", "K072627", "K212054", "K081137", "K120215", "K223080", "K113706", "K252350", "K112263", "K173842", "K242427", "K243641", "K101743", "K203632", "K250442", "K222827", "K170713", "K261824", "K240723", "K240502", "K171388", "K170879", "K191529", "K240852", "K050005", "K192877", "K143217", "K220889", "K250786", "K142683", "K173415", "K211325", "K171632", "K152448", "K153276", "K042855", "K212101", "K171120", "K172643", "K082497", "K182421", "K162973", "K253986", "K140553", "K080291", "K131861", "K200473", "K261823", "K180351", "K181517", "K123840", "K173337", "K182371", "K182140", "K183098", "K140189", "K002489", "K040237", "K011281", "K202166", "K243582", "K121921", "K192803", "K251324", "K202834", "K122532", "K110451", "K183224", "K043288", "K173906", "K191280", "K231798", "K161178", "K040948", "K081207", "K212747", "K060391", "K171699", "K152892", "K190999", "K161271", "K170508", "K251202", "K223095", "K211316", "K050802", "K123463", "K130726", "K150284", "K123329", "K202968", "K141077", "K242318", "K241638", "K043153", "K232773", "K251426", "K112208", "K230033", "K112584", "K110639" ], "registration_number": [ "1650907", "3007303113", "3001592626", "3014579024", "2022435", "2936485", "2032112", "3044545674", "3010885402", "3005369776", "3016832577", "1721686", "3011390076", "3013942591", "3017619652", "3009161688", "3012453745", "3015241782", "3042940623", "3038187466", "3008309062", "3018907196", "3002259632", "3012811961", "3015612252", "3036035332", "3013283620", "3016096100", "3009941480", "3048246462", "3016079756", "1061124", "3013077751", "3014663814", "3010564249", "3014309390", "3014656892", "3020331900", "2029015", "3004784537", "3033507886", "3001556604", "3018126215", "3003537036", "3013665681", "3015153469", "3007487007", "3009217531", "3016607092", "3022626486", "3004111573", "3011459762", "8043980", "1531174", "3014635169", "3007029079", "1058584", "3010860245", "8043903", "3014644276", "3010684280", "3038188839", "9611665", "3010493171", "3016555232", "3042953929", "3015224777", "3017820152", "3033043422", "8010877", "3009719225", "3007111496", "3003898360", "1226146", "2011171", "8010456", "2032098", "3010157088", "3010193531", "3001675293", "3013868968", "3011063460", "2246552", "2955842", "3031594238", "9616517", "3010432890", "3008837339", "9681503", "3017636737", "3015895145", "3017119401", "9614969", "3013188547", "2029275", "3015336263", "3012627460", "3026606306" ], "fei_number": [ "3007303113", "3001592626", "3014579024", "2022435", "2936485", "3044545674", "3010885402", "3002477156", "3008615487", "3005369776", "3016832577", "1000306431", "3003058448", "1721686", "1000512168", "3011390076", "3002807793", "3013942591", "3017619652", "3009161688", "3012453745", "3015241782", "3042940623", "3038187466", "3008309062", "3018907196", "3002259632", "3012811961", "3015612252", "3036035332", "3013283620", "3002808088", "3016096100", "3009941480", "3048246462", "3016079756", "3013077751", "3014663814", "3010564249", "3014309390", "3014656892", "3020331900", "3004784537", "3033507886", "3001556604", "3018126215", "3002914049", "3003537036", "3013665681", "3942", "3015153469", "3007487007", "3009217531", "3016607092", "3022626486", "3004111573", "3011459762", "3014635169", "3007029079", "3010860245", "3010684280", "3038188839", "3010493171", "3002681132", "3003076831", "3003117688", "1000160458", "1000219637", "3016555232", "3042953929", "3015224777", "3017820152", "3033043422", "3009719225", "3002680121", "3007111496", "3003898360", "3002993297", "2011171", "3010157088", "3010193531", "3001675293", "3006149253", "3013868968", "3011063460", "2246552", "3031594238", "1000499348", "3010432890", "3008837339", "3002807095", "3017636737", "3015895145", "3017119401", "3013188547", "3015336263", "3012627460", "3026606306" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }