{ "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": "219087", "product_res_number": "Z-2046-2026", "event_date_initiated": "2026-04-02", "event_date_posted": "2026-05-01", "recall_status": "Open, Classified", "res_event_number": "98564", "product_code": "NAY", "k_numbers": [ "K131861", "K171294" ], "product_description": "Brand Name: Da Vinci X and Da Vinci Xi\nProduct Name: da Vinci X, Xi Surgical System\nModel/Catalog Number: IS4000; IS4200\nSoftware Version: N/A\nProduct Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery.\nComponent: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument", "code_info": "Lot Code: UDI: 00886874114216\nFDA Medical Device Listing Number: D531324\nSee attachment Affected Product List \n\n\nUDI: 00886874114216\nFDA Medical Device Listing Number: D295931\nSee attachment Affected Product List", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Shahbaz Khan\n1-408-5232443", "reason_for_recall": "Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.", "root_cause_description": "Nonconforming Material/Component", "action": "On 04/02/2026, the firm sent via 2-day mailing service an \"Urgent Medical Device Correction\" letter to customers informing them that Intuitive identified that the screws on the cannula mount of the USM from a specific population are susceptible to breaking over time. When the cannula mount experiences a breakage of all six screws, the mount can separate from the rest of the USM. Breakage of any fewer than six screws will not result in cannula mount separation, or impact to clinical performance.\n\nHow to recognize issue/failure:\nScrew breakage or cannula mount loosening may be observable as visible or tactile separation of the cannula mount from the body of the USM.\nPrior to a procedure, closely inspect the joint between the cannula mount and insertion\naxis that is joined by the screws in Figure 1 in the Urgent Medical Device Correction Letter. Manipulate the cannula mount joint by hand to ensure there is no movement or looseness. If looseness or separation is observed, discontinue use of the USM and contact representative to schedule a site visit.\nIf all six screws were to break intra-operatively, the user may also observe imprecise or\nunintended instrument tip motion. If observed imprecise or unintended instrument\ntip motion, inspect the cannula mount for looseness or separation and if present,\ndiscontinue use of the USM and contact representative to schedule a site visit.\n\nCustomers are instructed to:\n1. This notice needs to be passed on to all those who need to be aware within your\norganization or functions where the potentially affected devices have been transferred.\n2. Retain a copy of letter, place with your affected system, and keep a copy of the acknowledgement form for your files.\n\nFor Questions:\nNorth/South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail:\ncustomerservice@intusurg.com.\nEurope/Middle East/Asia/Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com\nSouth Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support", "product_quantity": "2781", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.", "openfda": { "k_number": [ "K200049", "K170879", "K171120", "K141075", "K130726", "K230033", "K080291", "K061260", "K223095", "K150837", "K183107", "K231798", "K232773", "K212747", "K251227", "K241638", "K143217", "K254192", "K131962", "K162411", "K183224", "K081207", "K162973", "K240852", "K101743", "K243641", "K253556", "K170875", "K170644", "K122532", "K022574", "K211595", "K040237", "K183098", "K012833", "K192717", "K200473", "K242318", "K241814", "K060391", "K252069", "K213710", "K181517", "K123840", "K183086", "K222827", "K081137", "K171426", "K180351", "K143132", "K040948", "K110451", "K173337", "K112584", "K251324", "K182421", "K152448", "K161178", "K042855", "K191482", "K002489", "K220023", "K141077", "K171294", "K050802", "K172643", "K170645", "K261824", "K161271", "K240502", "K223080", "K251213", "K140189", "K241284", "K082497", "K030578", "K110639", "K243714", "K150284", "K050369", "K171388", "K063220", "K152578", "K171947", "K191529", "K153276", "K182140", "K202834", "K171632", "K220889", "K232610", "K021036", "K140553", "K203632", "K173721", "K180033", "K202968", "K011281", "K152421", "K211325", "K021152", "K990144", "K191736", "K251202", "K093217", "K171699", "K252675", "K130266", "K242427", "K222839", "K043153", "K121921", "K202571", "K131861", "K180163", "K233866", "K011002", "K101581", "K170713", "K170641", "K211316", "K251426", "K214095", "K170508", "K173585", "K231224", "K142683", "K182371", "K212054", "K212101", "K253986", "K043288", "K191280", "K250442", "K251817", "K250674", "K151794", "K152892", "K123329", "K090993", "K113706", "K120215", "K211997", "K243582", "K211784", "K210918", "K251739", "K240723", "K050005", "K072627", "K190999", "K192877", "K173842", "K260695", "K070947", "K202166", "K170865", "K173906", "K250786", "K192803", "K112208", "K252350", "K173415", "K123463", "K112263" ], "registration_number": [ "3016607092", "3005369776", "3042953929", "1061124", "3020331900", "3010157088", "2936485", "3011063460", "3031594238", "3012811961", "3010860245", "9681503", "3018907196", "3011390076", "3012627460", "3014579024", "3010564249", "1721686", "9614969", "3010193531", "3022626486", "8010456", "1058584", "3016079756", "3038187466", "3013283620", "3014663814", "3016555232", "3009719225", "2032098", "3017119401", "3012880598", "3015224777", "9611665", "3015895145", "3036035332", "3042940623", "1650907", "3014644276", "3039523130", "3015336263", "3010684280", "3014635169", "3008309062", "3009217531", "3048246462", "8010877", "3026606306", "2032112", "3015153469", "2022435", "3038284218", "3007029079", "3003898360", "3013665681", "3038188839", "3015612252", "3013077751", "2955842", "3001675293", "3009161688", "3016096100", "1531174", "3007111496", "3017619652", "3017820152", "3013868968", "3004784537", "2029015", "3003537036", "2011171", "3011459762", "3017636737", "3002259632", "3010432890", "3007303113", "3007487007", "3015241782", "3016832577", "3008837339", "3013942591", "2246552", "3010885402", "8043903", "9616517", "3014309390", "3014656892", "3033507886", "3013188547", "3004111573", "3018126215", "3001592626", "2029275", "3044545674", "3009941480", "3012453745", "1226146", "3010493171", "3007593944" ], "fei_number": [ "3016607092", "3005369776", "3042953929", "3020331900", "3010157088", "2936485", "3011063460", "3031594238", "3012811961", "3010860245", "3018907196", "3002807793", "3011390076", "3012627460", "3014579024", "3002807095", "3010564249", "1721686", "3010193531", "3022626486", "3016079756", "1000512168", "3038187466", "3013283620", "3014663814", "3016555232", "1000306431", "3009719225", "3017119401", "3002993297", "3012880598", "3015224777", "1000499348", "3015895145", "3036035332", "3002808088", "3042940623", "3039523130", "3015336263", "3010684280", "3014635169", "3008309062", "3009217531", "3048246462", "3026606306", "3015153469", "2022435", "3038284218", "3006149253", "3007029079", "3003898360", "3013665681", "3038188839", "3015612252", "3013077751", "3001675293", "1000219637", "3009161688", "3016096100", "3007111496", "3017619652", "3017820152", "3013868968", "3004784537", "3002681132", "3008615487", "1000160458", "3002477156", "3003537036", "2011171", "3011459762", "3017636737", "3942", "3002259632", "3010432890", "3007303113", "3007487007", "3015241782", "3016832577", "3008837339", "3013942591", "2246552", "3010885402", "3014309390", "3014656892", "3033507886", "3013188547", "3004111573", "3018126215", "3003058448", "3001592626", "3002680121", "3044545674", "3009941480", "3012453745", "3003076831", "3010493171", "3007593944", "3003117688" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }