{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Sunnyvale",
      "address_1": "1266 Kifer Rd Bldg 100",
      "reason_for_recall": "Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in  unexpected master movement and potential instrument tip movement under certain circumstances",
      "address_2": "",
      "product_quantity": "677 devices",
      "code_info": "All systems manufactured with or upgraded to P5 software.",
      "center_classification_date": "20161026",
      "distribution_pattern": "Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South  Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States",
      "state": "CA",
      "product_description": "da Vinci¿ Xi\" Surgical System, model number IS4000, A70_P5x with P5 Software;    General and Plastic Surgery:  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.",
      "report_date": "20161102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Intuitive Surgical, Inc.",
      "recall_number": "Z-0315-2017",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "75473",
      "termination_date": "20170501",
      "more_code_info": "",
      "recall_initiation_date": "20161005",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}