{ "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": "166162", "product_res_number": "Z-2835-2018", "event_date_initiated": "2018-05-17", "event_date_created": "2018-08-16", "recall_status": "Open, Classified", "res_event_number": "80691", "product_code": "NAY", "k_numbers": [ "K131861" ], "product_description": "The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller.\nModel Number: \n372601-16.", "code_info": "UDI Number: 00886874114193. Serial Number: SK1703.", "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": "408-523-2100", "reason_for_recall": "An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.", "root_cause_description": "Use error", "action": "Intuitive Surgical notified customers via a \"Field Safety Notice\nUrgent Medical Device Correction ISIFA2018-06-C\nda Vinci Xi Miscalibrated Endoscope Controller\" letter. The letter provided: Reason for Field Action, Risk to Health, Affected Products (description, part number, serial number), Action taken by Intuitive Surgical, Actions to be taken by the Customer/ User, contact information for Further Information & Support, and an Acknowledgement Form.", "product_quantity": "1", "distribution_pattern": "U.S.", "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", 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