{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122550", "product_res_number": "Z-0139-2014", "event_date_initiated": "0012-11-30", "event_date_posted": "2013-11-04", "recall_status": "Terminated", "event_date_terminated": "2013-11-04", "res_event_number": "66526", "product_code": "NAY", "k_numbers": [ "K050369", "K081137" ], "product_description": "Patient Cart used in conjunction with the da Vinci S surgical and SI System.\r\n\r\nIntuitive Surgical\r\n1266 Kifer Road\r\nSunnyvale, CA 94086\r\n\r\nThe Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator.", "code_info": "Model IS2000 and IS 3000", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 100 1266 Kifer Rd", "address_2": "Bldg 100", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Richard Reeves\n408-523-2244", "reason_for_recall": "Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.", "root_cause_description": "Device Design", "action": "Intuitive Surgical Inc sent an Product Notification to all affected customers via email on November 30, 2012.\r\n\r\nE-mail notifications advised users of an addendum to the User Manual for Covering the Patient Cart column that provided a recommended method for covering the da Vinci patient cart column to prevent splashing on the cart during a procedure. The addendum was attached to the e-mail and is available online.\r\n\r\nIf you have any questions, please contact Customer Service at 1-800-876-1310. Outside the United States call +41 21 821 2020 or +800.0821.2020", "product_quantity": "1754 patient carts", "distribution_pattern": "Worldwide Distribution - USA including Puerto Rico and the countries of Australia, Austria, Argentina, Belgium, Bulgaria, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Japan, Kuwait, Mexico, Netherlands, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay and Venezuela.", "openfda": { "k_number": [ "K011281", "K242427", "K151794", "K161178", "K183107", "K140553", "K161271", "K101581", "K183224", "K253986", "K192803", "K191482", "K170879", "K251324", "K212747", "K173415", "K173721", "K200049", "K043153", "K241638", "K143132", "K171699", "K040948", "K110639", "K142683", "K170641", "K122532", "K202968", 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