{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215186",
      "product_res_number": "Z-2486-2025",
      "event_date_initiated": "2025-07-22",
      "event_date_posted": "2025-09-02",
      "recall_status": "Open, Classified",
      "res_event_number": "97311",
      "product_code": "QVA",
      "product_description": "RefleXion X1 Model RXM1000\nUDI Codes:\n(01)00860003983812(11)230504(21)X11001\n(01)00860003983812(11)230518(21)X11002\n(01)00860003983812(11)230505(21)X11003\n(01)00860003983812(11)230530(21)X11004\n(01)00860003983812(11)230811(21)X11006\n(01)00860003983812(11)230410(21)X11007\n(01)00860003983812(11)230803(21)X11008\n(01)00860003983812(11)240528(21)X11009\n(01)00860003983812(11)240820(21)X11010\n(01)00860003983812(11)241107(21)X11011\n(01)00860003983812(11)241206(21)X11012\n\nThe RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator.  The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography\ndetection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.",
      "code_info": "Model Number: RXM1000\nUDI Codes that includes Serial Numbers:\n(01)00860003983812(11)230504(21)X11001\n(01)00860003983812(11)230518(21)X11002\n(01)00860003983812(11)230505(21)X11003\n(01)00860003983812(11)230530(21)X11004\n(01)00860003983812(11)230811(21)X11006\n(01)00860003983812(11)230410(21)X11007\n(01)00860003983812(11)230803(21)X11008\n(01)00860003983812(11)240528(21)X11009\n(01)00860003983812(11)240820(21)X11010\n(01)00860003983812(11)241107(21)X11011\n(01)00860003983812(11)241206(21)X11012",
      "firm_fei_number": "3011716550",
      "recalling_firm": "Reflexion Medical, Inc.",
      "address_1": "25881 Industrial Blvd",
      "city": "Hayward",
      "state": "CA",
      "postal_code": "94545-2991",
      "additional_info_contact": "Diana King\n858-951-6926",
      "reason_for_recall": "Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).",
      "root_cause_description": "Software change control",
      "action": "On 07/22/2025, the firm sent an \"Urgent Medical Device Recall Safety Notification (Correction)\" Letter to customer informing them that RefleXion is initiating a Recall (Correction) of the RefleXion X1 System (model RXM1000). An issue has been identified with a configuration setting for the maximum number of fractions that can be delivered within a specified time period. The system should be configured to allow the delivery of up to two (2) fractions, including completion of partial fractions, for each treatment plan within a 12-hour period. As a result of this issue there is a potential to unintentionally administer more than two treatments in a 12-hour period, potentially leading to serious toxicity.\n\nCustomer are instructed to:\n1) Acknowledge receipt of the email by signing and returning the attached  Consignee Acknowledgment Form  at their earliest convenience.\n2) Until the configuration setting is corrected, RefleXion Medical advises users to employ current radiation therapy procedures within the clinic to perform daily checks of treatment session records for radiation therapy patients to prevent delivery of unintended fractions.\n3) It is requested that customers post this notification on or near the RefleXion Medical RXM1000 system until this issue can be resolved.\n\nFor questions or assistance - email support@reflexion.com",
      "product_quantity": "11",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.",
      "openfda": {
        "k_number": [
          "K252071",
          "DEN220014"
        ],
        "registration_number": [
          "3011716550"
        ],
        "fei_number": [
          "3011716550"
        ],
        "device_name": "Fludeoxyglucose F18-Guided Radiation Therapy System",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5060",
        "device_class": "2"
      }
    }
  ]
}