{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 8 } }, "results": [ { "cfres_id": "217489", "product_res_number": "Z-0964-2026", "event_date_initiated": "2024-08-21", "event_date_posted": "2025-12-19", "recall_status": "Open, Classified", "res_event_number": "98048", "product_code": "NAY", "k_numbers": [ "K232610" ], "product_description": "da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40", "code_info": "UDI-DI: 00886874119747. Serial Numbers:\n10476314,\n10485693,\n10496049,\n10497992,\n10503432,\n10503433,\n10507302,\n10509551,\n10511044,\n10511047,\n10516467,\n10518960,\n10518961,\n10522438,\n10522439,\n10522441,\n10523771,\n10523773,\n10523775,\n10523776,\n10523777,\n10523778,\n10523779,\n10523780,\n10523781,\n10529917,\n10529918,\n10529919,\n10529920,\n10529922,\n10534426,\n10534428,\n10534429,\n10534430,\n10534752,\n10534753,\n10534754,\n10534755,\n10534757,\n10543027,\n10543028,\n10543048,\n10543051,\n10544670,\n10544676,\n10544677,\n10544678,\n10547713,\n10547717,\n10547724,\n10547728,\n10551553,\n10551554,\n10552616,\n10552618,\n10552620,\n10552621,\n10556681,\n10556682,\n10558195,\n10558197,\n10558198,\n10558202,\n10560603,\n10560604,\n10560607,\n10562584,\n10562585,\n10562586,\n10562588,\n10565609,\n10565610,\n10565614,\n10567141,\n10567143,\n10567145,\n10569365,\n10569367,\n10569368,\n10569369,\n10570704,\n10570705,\n10570706,\n10570707,\n10573677,\n10573678,\n10573679,\n10573680,\n10573681,\n10573682,\n10573683,\n10573684,\n10573685,\n10573686,\n10576019,\n10576021,\n10576022,\n10576023,\n10576024,\n10576025,\n10576026,\n10576027,\n10576028,\n10579442,\n10579446,\n10579453,\n10579455,\n10579456,\n10579457,\n10579461,\n10579466,\n10582427,\n10582428,\n10582429,\n10591177,\n10591179,\n10591180,\n10591184,\n10591197,\n10594614,\n10594615,\n10594616,\n10594617,\n10594618,\n10594619,\n10597107,\n10597108,\n10597109,\n10597110,\n10599042,\n10599044,\n10599045,\n10599048,\n10600750,\n10600753,\n10603334,\n10603335,\n10603343,\n10603344,\n10603345,\n10603367,\n10605468,\n10606129,\n10606133", "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\n408-523-2443", "reason_for_recall": "Surgical system Error 23062 due to connector1) Partially damaged \"Potential problem with ergonomics: Disable - Retry \" or 2) Failed \"Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable\" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure", "root_cause_description": "Device Design", "action": "On 8/21/2024, correction notices were sent to customers who were informed of the following:\n\n1) Share this notification with all personnel at your site who perform and support da Vinci procedures.\n2) Inform affected personnel when the correction has been completed.\n3) Complete and return the acknowledgement form via email to Recalls@intusurg.com\n4) Retain a copy of this letter and the acknowledgement form for your files.\n5) Firm is actively working on making updated motor module assemblies available. Once available, an Intuitive representative will schedule a visit to replace the affected motor module sub-assembly.\n\nIf you need further information or support concerning this notification, please contact the firm's Customer Service: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com", "product_quantity": "144", "distribution_pattern": "US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.", "openfda": { "k_number": [ "K242427", "K002489", "K143132", "K043288", "K072627", "K070947", "K250442", "K123840", "K232610", "K093217", "K153276", "K202166", "K211595", "K253556", "K242318", "K040237", "K241638", "K183107", "K202968", "K121921", "K161271", "K061260", "K251227", "K110451", "K171120", "K171699", "K202834", "K261824", "K063220", "K251213", "K230033", "K200473", "K183098", "K182140", "K183224", "K040948", "K260695", 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