{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195973", "product_res_number": "Z-0133-2023", "event_date_initiated": "2022-09-20", "event_date_posted": "2022-10-25", "recall_status": "Open, Classified", "res_event_number": "90826", "product_code": "NAY", "k_numbers": [ "K131861", "K171294" ], "product_description": "da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)", "code_info": "Software version P10 (OS4 v10.0.0/A70_P10_B738) \n\nSOFTWARE,EMBEDDED RLS,IS4000 AND IS4200,A70_P10_B738 (Model: 610092-738) on Model Name/Model Number/UDI-DI:\nASSY,PSCART,IS4000,4-ARM,P10/380652-55/00886874110720,\nASSY,SSC,IS4000,P10/380677-28/00886874110744,\nASSY,VSS VISION SYSTEM,IS4000,P10/381121-45/00886874110898,\nASSY,PSCART,IS4200,P10/380620-47/00886874115404,\nASSY,VSC,IS4000,RECONDITIONED,P10/380721-15/00886874115343,\nASSY,SSC,IS4000,RECONDITIONED,P10/380723-16/00886874115374", "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": "Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery", "root_cause_description": "Software Design Change", "action": "On 09/20/22, correction notices were mailed to customers.\nCustomers were advised of the following:\n1) The system software version can be located on the Vision Cart Touchscreen in the Troubleshooting Tab.\n2) Ensure all device users read and understand this notice.\n3) Notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.\n4) Ensure proper instrument connections to the generator(s) and continue to follow all existing warnings and cautions found in user manuals 551400-15, USER MANUAL,SYS,P10,US,IS4000, 553873-07, USER MANUAL,I-A,MDR P10,IS4000-IS4200 and 554070-04, ADD,I-A,FORCE BIPOLAR,IS4000,IS4200.\n5) Complete and return the acknowledgement form.\n6) The recalling firm will follow-up with customers and schedule a software upgrade. \n7) After the upgrade, inform all personnel that the software update/upgrade was completed.\n8) If you have experienced this issue or require additional assistance, contact Technical Support: 800-876-1310, Option 1 (24/7) or customerservice@intusurg.com", "product_quantity": "162", "distribution_pattern": "US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC", "openfda": { "k_number": [ "K011281", "K242427", "K151794", "K161178", "K183107", "K140553", "K161271", "K101581", "K183224", "K253986", "K192803", "K191482", "K170879", "K251324", "K212747", "K173415", "K173721", "K200049", "K043153", "K241638", "K143132", "K171699", "K040948", "K110639", "K142683", "K170641", "K122532", "K202968", "K252675", "K231798", "K152578", "K230033", "K123840", "K191280", "K050005", "K061260", "K254192", "K211316", "K191529", "K143217", "K222839", "K211325", "K171388", "K242318", "K180351", "K121921", "K171632", "K250442", "K021152", "K123329", "K070947", "K131962", "K021036", "K241284", "K150837", "K202834", "K130726", "K152448", "K162411", "K261824", "K990144", "K173906", 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"device_class": "2" } } ] }