{ "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": "219527", "product_res_number": "Z-2521-2026", "event_date_initiated": "2026-04-22", "event_date_posted": "2026-06-22", "recall_status": "Open, Classified", "res_event_number": "98701", "product_code": "NAY", "k_numbers": [ "K173906", "K182371" ], "product_description": "Da Vinci ASSY, PSS, SP1098, Part Number: 380601", "code_info": "UDI: 00886874114605. 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In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.", "root_cause_description": "Process control", "action": "On 4/22/2026, correction notices were mailed and emailed to customers who were asked to do the following:\n1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred.\n2. Please retain a copy of this letter, place a copy with your affected system, and keep a copy of the acknowledgement form for your files.\n3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form.\n\nA firm Representative will schedule a site visit to perform an inspection of the system.\n\n If you need further information or support concerning this Medical Device Correction, please contact your da Vinci SP Sales Representative or contact Intuitive Customer Service at the numbers listed below: \n\"\tNorth and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com.\n\"\tEurope, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com\n\"\tSouth Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com \n\"\tJapan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com \n\"\tIndia: +1-800-103-6952 (9 am to 6 pm IT)\n\"\tTaiwan: +0800-86-8181 (9 am to 6 pm CT)", "product_quantity": "454", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania.", "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", 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"3003076831", "3010493171", "3007593944", "3003117688" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }