{ "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": "194435", "product_res_number": "Z-1484-2022", "event_date_initiated": "2022-06-22", "event_date_created": "2022-08-01", "recall_status": "Open, Classified", "res_event_number": "90452", "product_code": "NAY", "k_numbers": [ "K191280" ], "product_description": "The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.", "code_info": "Model Number: 374848-09\nUDI -DI Code: 00886874116982\nSystem Serial 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"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": "Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.", "root_cause_description": "Process design", "action": "On 06/20/2022, the firm sent out an \"Medical Device Correction\" letter via US direct Mail to customers informing them that the firm became aware that certain testing requirements were not performed during the annual preventative maintenance process for certain E-100 Generators. Specifically, output power calibration, to confirm adherence to specifications for energy delivery to compatible devices, and electrical safety testing, to ensure electrical isolation and ground connection.\n\nCustomers are instructed that they can continue to use the E-100 Generators and to:\n1. Notify all affected hospital personnel about this Medical Device Correction.\n2. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form.\n3. Please retain a copy of this letter and the acknowledgement form for their files.\n4. Please inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process.\n5. Additionally, if Adverse Events*/Serious Incidents** or quality problems are\nexperienced, please follow your standard reporting process to your health authority, if applicable.\n6. Notify affected personnel when the affected product has been replaced by the Intuitive representative.\n\nFor questions or further assistance:\n- US, Puerto Rico and Dominican Republic (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com\n- Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com\n- Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com", "product_quantity": "505 generators", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. 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