{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190523", "product_res_number": "Z-0419-2022", "event_date_initiated": "2021-09-22", "event_date_created": "2021-12-27", "recall_status": "Open, Classified", "res_event_number": "89109", "product_code": "NAY", "k_numbers": [ "K173906", "K182371", "K192717", "K202968", "K211316", "K211595" ], "product_description": "da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI:\n\nASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605\nASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735\nASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742\nSOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A", "code_info": "All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)", "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": "Karen Smith\n408-523-2100", "reason_for_recall": "Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.", "root_cause_description": "Software design", "action": "On 09/22/2021, the firm notified affected customers via mail of \"Urgent Medical Device Correction - ISIFA2021-04-C.\" The letter indicated, \"As part of the field action process, please complete the actions below:\n\n1. Ensure that all personnel who use the da Vinci SP System read and understand the contents of this letter.\n2. Inform the personnel when the software update has been completed by the Intuitive representative.\n3. Complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form.\n4. Retain a copy of this letter and the acknowledgement form for your files.\n5. Contact Technical Support at the number listed below for assistance if you have experienced this issue: US Technical Support: 800-876-1310, Option 1 (24/7)\n\nAn Intuitive representative will schedule a site visit to install the next available software update.\n\nIf you require further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below:\n-US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com.\"", "product_quantity": "46", "distribution_pattern": "US Nationwide distribution in the states of Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.", "openfda": { "k_number": [ "K182140", "K261824", "K192803", "K251227", "K081137", "K210918", "K173721", 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