{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Sunnyvale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90826",
      "recalling_firm": "Intuitive Surgical, Inc.",
      "address_1": "1266 Kifer Rd Bldg 101",
      "address_2": "N/A",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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",
      "recall_number": "Z-0133-2023",
      "product_description": "da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)",
      "product_quantity": "162",
      "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",
      "recall_initiation_date": "20220920",
      "center_classification_date": "20221025",
      "report_date": "20221102",
      "code_info": "Software version P10 (OS4 v10.0.0/A70_P10_B738)   SOFTWARE,EMBEDDED RLS,IS4000 AND IS4200,A70_P10_B738 (Model: 610092-738) on Model Name/Model Number/UDI-DI: ASSY,PSCART,IS4000,4-ARM,P10/380652-55/00886874110720, ASSY,SSC,IS4000,P10/380677-28/00886874110744, ASSY,VSS VISION SYSTEM,IS4000,P10/381121-45/00886874110898, ASSY,PSCART,IS4200,P10/380620-47/00886874115404, ASSY,VSC,IS4000,RECONDITIONED,P10/380721-15/00886874115343, ASSY,SSC,IS4000,RECONDITIONED,P10/380723-16/00886874115374",
      "more_code_info": ""
    }
  ]
}