{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217883", "product_res_number": "Z-1428-2026", "event_date_initiated": "2025-11-17", "event_date_posted": "2026-02-18", "recall_status": "Open, Classified", "res_event_number": "98200", "product_code": "NAY", "k_numbers": [ "K232610" ], "product_description": "Da Vinci 5 \nASSY, DV5 CONSOLE, IS5000\nModel/Catalog Number: 380730 \nUsed for minimally invasive surgery.", "code_info": "UDI-DI: 00886874119747\nGTIN: 0886874119747\nwith software version P1.2.1", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Shahbaz Khan\n1-408-5232443", "reason_for_recall": "An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.", "root_cause_description": "Software Design Change", "action": "On 11/17/2025, the firm emailed a \"New Customer Communication\" to customers informing them that Intuitive has become aware, following the distribution of P1.2.1 software version for dV5 Systems between October 17, 2025 and October 24, 2025, of an increase in 48306 error events observed on Da Vinci 5 Surgical Systems in dual console configuration, causing User Interface (UI) application crashes and loss of interaction at the affected node.\n\nCustomers are instructed to:\nContinue Safe Use:\nIf error 48306 occurs, follow the on-screen instructions and select Retry to recover.\nAffected systems may continue to be used following the recovery of error 48306 with the\nawareness of potential loss of non-essential UI features as outlined below:\n\" User interface may not be displayed on connected external monitor live\nendoscopic video is still displayed\n\" User interface may not be displayed on the dV5 Tower monitor - live endoscopic\nvideo is still displayed\n\" System may be unable to activate Tile/Overlay layout user is unable to stream\nvideo input from external sources into the Console viewer.\nIf UI streaming remains unavailable, restart the system during the procedure to\nrestore full functionality. Guidance is available in Appendix B, Faults that Require\nRestarting , of Da Vinci 5 User Manual PN 555500-05.\nIntuitive Surgical is developing a corrective software patch (version P1.2.2). When ready, customers will be contacted to schedule installation.\nPlease take the additional following actions:\n1. Display this communication with systems; ensure it is in a place likely to be seen/viewed by operators.\n2. Retain a copy of this letter and the acknowledgement form for your files.\n\nFor questions - contact Intuitive Representative or contact Intuitive Customer Service at:\n(800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com.", "product_quantity": "12", "distribution_pattern": "US distribution: LA, MA, NY, PA, TX, and VA.", "openfda": { "k_number": [ "K121921", "K251817", "K250674", "K173721", "K112208", "K123463", "K060391", "K222827", "K011002", "K050369", "K080291", "K110639", "K170645", "K191280", "K131962", "K152578", "K002489", "K251324", "K152421", "K170879", "K202968", "K143217", "K173337", "K090993", "K170641", "K212054", "K173585", "K173842", "K240723", "K050005", "K122532", "K182140", "K241814", "K170865", "K161271", "K220023", "K150284", "K243641", "K253986", "K021152", "K043153", "K130726", "K150837", "K251213", "K081137", "K152448", "K101581", "K142683", "K171632", "K211595", "K241638", "K243714", "K170713", "K112584", "K040237", "K252350", 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"medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }