{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198066", "product_res_number": "Z-1293-2023", "event_date_initiated": "2023-02-10", "event_date_posted": "2023-03-28", "recall_status": "Open, Classified", "res_event_number": "91503", "product_code": "NAY", "k_numbers": [ "K131861", "K171294" ], "product_description": "da Vinci Xi Surgical System Model IS4000\n\nda Vinci X Surgical System Model IS4200", "code_info": "da Vinci Xi Surgical System Model IS4000\nda Vinci X Surgical System Model IS4200\nPart Number: 380647\nUDI-DI Code: 00886874114216\nSerial 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SL1024\nSL1027\nSL1028\nSL1029\nSL1030\nSL1031\nSL1032\nSL1033\nSL1035\nSL1037\nSL1040\nSL1042\nSL1043\nSL1044\nSL1047\nSL1054\nSL1055\nSL1062", "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": "Alex Mathews\n408-523-2100", "reason_for_recall": "Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.", "root_cause_description": "Equipment maintenance", "action": "On 02/10-13/2023, Intuitive Surgical sent \"Urgent Medical Device Correction\" letters via email to inform two Groups of Customer (Group 1 and Group 2) that, a population of da Vinci Z and Xi Systems instrument arms (USMs-Universal Surgical Manipulators) have instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor which prevents free-fall motion or complete detachment from the USM. However, the Instrument Carriage may feel like it is not tightly connected to the rail. This condition may also lead to increased friction along the insertion axis.\n\nInstructions for Customers in Group 1 (reference Appendix A of their Letter): Stop/Cease use of the affected systems until Intuitive Representatives can replace the affected USMs on their systems.\n\nInstructions for Customers in Group 2 (reference Appendix B of their Letter): Can continue to use affected systems, but prior to each use, need to perform inspection of all the instrument carriages using the \"Instrument Carriage Inspection Instructions\" (refer letter for details of inspection).\n\nFor questions or additional guidance:\n-US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.\n-Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com\n-South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com\n-Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com\n-Taiwan: 886-2-2-27008181 (9 AM to 6:00 PM CST) or CS.taiwan@intusurg.com\n-India: 1800 103 6952 (9:00 AM to 6:00 PM IST) or Email address: support.india@intusurg.com", "product_quantity": "1,225 total USMs", "distribution_pattern": "U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States\n\nO.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam", "openfda": { "k_number": [ "K173721", "K251202", "K122532", "K240502", "K170879", "K130266", "K131861", "K141077", "K183086", "K202834", "K112584", "K231798", "K182421", "K153276", "K182371", "K171699", "K050369", "K252350", "K171120", "K152578", "K123329", "K250674", "K990144", "K191529", "K170713", "K123463", "K082497", "K180033", "K211595", "K173415", "K093217", "K192803", "K072627", "K162411", "K121921", "K011002", "K060391", "K213710", "K252069", "K214095", "K030578", "K043153", "K173906", "K183224", "K240852", "K191482", "K170641", "K253556", "K021036", "K243582", "K042855", "K253986", "K162973", "K161178", "K240723", "K143132", "K140189", "K251227", "K183107", "K251213", "K172643", "K203632", "K220889", "K190999", "K261824", "K191280", "K081207", "K200049", "K212054", "K222827", "K050005", "K250442", "K171426", "K152892", "K220023", "K254192", "K241284", "K202571", "K241814", "K170865", "K192877", "K242427", "K080291", "K081137", "K173337", "K170875", "K191736", "K021152", 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