{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sunnyvale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69213",
      "recalling_firm": "Intuitive Surgical, Inc.",
      "address_1": "1266 Kifer Rd Bldg 100",
      "address_2": "N/A",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US nationwide and the countries of:  Belgium, Germany, China(Hong Kong), India, Israel, Italy, and the United Kingdom.",
      "recall_number": "Z-2731-2014",
      "product_description": "ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System.    Product Usage:  The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.",
      "product_quantity": "75 devices",
      "reason_for_recall": "Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.",
      "recall_initiation_date": "20140911",
      "center_classification_date": "20140929",
      "termination_date": "20141023",
      "report_date": "20141008",
      "code_info": "PATIENT SIDE CART, PS4000.   Part Number: 380652  Serial Numbers:  353668  351929  354943  351749  354389  351849  355824  363594  361993  360419  358104  357083  351852  351845  361323  358107  364412  364505  361994  364001  349166  364112  358774  359361  357082  363784  353632  364343  358109  358848  351052  354234  354552  356258  363752  354233  358775  364200  359222  364619  363868  354714  361989  361391  361094  351853  353410  355206  357698  358480  365395  359223  355996  363681  360417  355623  365465  365839  356530  364620  365928  365862  356532  366904  366884  367674  368046  367426  356683  360413  356533  368071  368681  358930  357081."
    }
  ]
}