{ "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": "65720", "product_res_number": "Z-0152-2008", "event_date_initiated": "2007-10-04", "event_date_posted": "2008-02-22", "recall_status": "Terminated", "event_date_terminated": "2011-03-31", "res_event_number": "45518", "product_code": "NAY", "k_numbers": [ "K021036", "K050369", "K063220", "K990144" ], "product_description": "Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA", "code_info": "SG015, SG053, SG060, SG067, SG096, SG126, SG151, SG164, SG201, SG245, SG267, SG269, SG270, SG271, SG272, SG273, SG275, SG276, SG278, SG280, SG282, SG283, SG285, SG286, SG287, SG288, SG289, SG290, SG291, SG292, SG293, SG294, SG295, SG296, SG297, SG298, SG299, SG300, SG301, SG302, SG303, SG309, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG323, SG324, SG325, SG326, SG329, and SG330", "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": "Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that", "root_cause_description": "Mixed-up of materials/components", "action": "A product recall was initiated on October 4, 2007. Direct and Distributor consignees were sent an Important Product Notice, via electronic mail on October 5, 2007. The firm plans on sending a Field Service Engineer to inspect the system and make any necessary corrections.", "product_quantity": "63 total units", "distribution_pattern": "Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, LA, MA, MD, MN, NC, NJ, NV, OH, PA, PR, SD, TN, TX, WA, and WI, and countries of Belgium, Ireland, Italy, Korea, Russia, and the United Kingdom.", "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", 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