{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221187",
      "product_res_number": "Z-2717-2026",
      "event_date_initiated": "2026-06-09",
      "event_date_posted": "2026-07-09",
      "recall_status": "Open, Classified",
      "res_event_number": "99280",
      "product_code": "SCV",
      "k_numbers": [
        "K252111"
      ],
      "product_description": "Brand Name: Versius Surgical System US\nProduct Name: Vesius Surgeon Console US\nModel/Catalog Number: V-SS-1020\nSoftware Version: Pratchett 1 version 62.1\nProduct Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system \ndesigned for surgeons to perform minimally invasive surgery.",
      "code_info": "UDI-DI 05060548211226\nModel No V-SS-1020\nSerial Numbers 66495, 66496\nSoftware Revision Version 62.1\nThere is no expiry date for this device.",
      "firm_fei_number": "3015488559",
      "recalling_firm": "CMR SURGICAL LIMITED",
      "address_1": "1 Evolution Business Park Milton Road Cam",
      "city": "Cambridge",
      "country": "United Kingdom",
      "additional_info_contact": "Gareth Hearn\n414-3731413",
      "reason_for_recall": "Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.",
      "root_cause_description": "Software design (manufacturing process)",
      "action": "On June 16, 2026, the firm began notifying affected customers. The firm or its local distributor will proactively carry out the secure boot configuration of the affected consoles.",
      "product_quantity": "2",
      "distribution_pattern": "US Nationwide distribution in the state of California.",
      "openfda": {
        "k_number": [
          "K260804",
          "K250725",
          "K252111",
          "DEN230078"
        ],
        "registration_number": [
          "2248148",
          "3015488559",
          "3004105270",
          "3010193531",
          "3017636737",
          "3008889904",
          "9611102",
          "3007029079",
          "3014155960",
          "3008132398",
          "3018094310",
          "9612501",
          "9614969",
          "3010372554",
          "3010408671",
          "1219930"
        ],
        "fei_number": [
          "3015488559",
          "3004105270",
          "3010193531",
          "3017636737",
          "3003495548",
          "3008889904",
          "3007029079",
          "3014155960",
          "3018094310",
          "3002808001",
          "3002807091",
          "3010372554",
          "1000222372",
          "1000499348",
          "3010408671",
          "1219930"
        ],
        "device_name": "Modular Electromechanical Surgical System",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4964",
        "device_class": "2"
      }
    }
  ]
}