{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150460", "product_res_number": "Z-0315-2017", "event_date_initiated": "2016-10-05", "event_date_posted": "2016-10-26", "recall_status": "Terminated", "event_date_terminated": "2017-05-01", "res_event_number": "75473", "product_code": "NAY", "k_numbers": [ "K131861" ], "product_description": "da Vinci Xi\" Surgical System, model number IS4000, A70_P5x with P5 Software;\n\nGeneral and Plastic Surgery:\nThe Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders,\nendoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic\nsurgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.", "code_info": "All systems manufactured with or upgraded to P5 software.", "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": "Mark Johnson\n408-523-2100", "reason_for_recall": "Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in\nunexpected master movement and potential instrument tip movement under certain circumstances", "root_cause_description": "Software design", "action": "Urgent Medical Device Correction letters were sent on October 12, 2016 by traceable method to all affected customers. Letters notify customers of the issue and provided instructions to prevent it from happening until ISI software can install new software upgrade in 1st Q 2017.", "product_quantity": "677 devices", "distribution_pattern": "Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South\nKorea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States", "openfda": { "k_number": [ "K152892", "K252350", "K122532", "K211997", "K254192", "K120215", "K171120", "K171947", "K223080", "K251817", "K140189", "K233866", "K123840", "K170875", "K253986", "K242318", "K240502", "K042855", "K170713", "K191280", "K123329", "K230033", "K093217", "K121921", "K173842", "K990144", "K131962", "K210918", "K231798", "K211595", "K182140", "K241814", "K214095", "K002489", "K253556", "K171632", "K161271", "K170508", "K080291", "K220889", 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