{ "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": "189521", "product_res_number": "Z-0275-2022", "event_date_initiated": "2021-09-21", "event_date_created": "2021-11-23", "recall_status": "Terminated", "event_date_terminated": "2024-01-25", "res_event_number": "88783", "product_code": "NAY", "k_numbers": [ "K131861" ], "product_description": "The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm.\nThe X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.", "code_info": "Part number: 470015-07; Lot number: DM4210309; REF: 470015; \nUDI # 00886874112199.", "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\n408-523-5313", "reason_for_recall": "Incorrect expiration date on its package labeling (shipper box and inner carton label).", "root_cause_description": "Labeling Change Control", "action": "On September 21, \"Urgent Medical Device Recall\"-customer letter was sent out to the affected sites, via FedEx and an updated letter with legible print of labels on October 21 to non-responder customers for incorrect expiration date on the package labeling (shipper box and inner carton) label. Both shipper and carton label had expiration date as 11/30/2023 instead of 01/31/2023. The Affected product is being requested to be returned per attached field safety notice (5556010-01 Rev A). The customers had been requested to fax or E-mail the acknowledgement form to, Attn: REGULATORY COMPLIANCE FIELD ACTIONS; Subject line for email: ISIFA2021-05-R Xi Drape Expiration Date\nU.S. Fax +1(408) 523-0619, or Scan and Email: Recalls@intusurg.com. \n\nThe firm expects customers to call or email the firm with the unused quantities to receive the replacement or credit to return the affected devices, if customers call or send an E-mail. The firm will provide RMA when customers call the firm. \n\nCustomers are advised to take actions as: Inform necessary hospital personnel about this issue.\n2. Locate all affected products at their site and return to the firm via the standard RMA process.\n3. Inform affected personnel when the requested actions have been completed.\n4. Complete the attached Acknowledgement Form immediately and return to the firm via fax or email as instructed on the form.\n5. Please retain a copy of this letter and the acknowledgement form for customer's files.\nReplacements will be provided against returned affected product.\nCustomers are provided contact information as: Customers Clinical Sales Representative or contact at the numbers listed below:\n\" North America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.\n\" South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)", "product_quantity": "1,740 drapes (87 bobes)", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.", "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", 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"K081137", "K112263", "K180033", "K203632", "K090993", "K171294", "K211595", "K173585", "K211997", "K182371", "K171947", "K251739", "K252069", "K243714", "K212101", "K202571", "K213710", "K183098", "K190999", "K170644", "K223080", "K240723", "K080291", "K112584", "K170865", "K150284", "K130266", "K211784", "K093217", "K212054", "K253556", "K202166", "K222827", "K171120", "K240502", "K232610", "K250674", "K072627", "K173842", "K231224", "K214095", "K192717", "K171426", "K240852", "K251426", "K030578", "K251213" ], "registration_number": [ "", "3010860245", "3010432890", "2029015", "3015224777", "3001592626", "1226146", "3015336263", "3007029079", "3014309390", "1058584", "3014663814", "2029275", "3007487007", "3009217531", "3017820152", "1531174", "3042940623", "3016607092", "3011390076", "3012811961", "3036035332", "3010684280", "3042953929", "3010157088", "3016096100", "3013868968", "8043903", "3033507886", "3013942591", "3007593944", "3011063460", "3031594238", "3038188839", "3010193531", "3010493171", "2936485", "2011171", "1721686", "3012627460", "2032112", "3003898360", "3004111573", "3009941480", "3038284218", "3012880598", "3039523130", "3015895145", "3016555232", "9611665", "3008309062", "3012453745", "3017636737", "8010877", "3014579024", "3013665681", "3005369776", "9681503", "8010456", "3009719225", "3003537036", "3002259632", "3016832577", "3017119401", "3022626486", "3007111496", "3014635169", "1061124", "1650907", "3038187466", "3009161688", "3014644276", "3007303113", "3008837339", "3013283620", "3013077751", "3013188547", "9614969", "3014656892", "3016079756", "2032098", "3018907196", "2246552", "3018126215", "9616517", "2022435", "3015612252", "3010564249", "3015153469", "3017619652", "3004784537", "3015241782", "3026606306", "3011459762", "3010885402", "2955842", "3001675293", "3020331900" ], "fei_number": [ "", "3010860245", "3010432890", "1000219637", "3015224777", "3001592626", "3015336263", "3007029079", "3014309390", "3014663814", 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