{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Hayward",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94533",
      "recalling_firm": "Reflexion Medical, Inc.",
      "address_1": "25881 Industrial Blvd",
      "address_2": "",
      "postal_code": "94545-2991",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: CA, CT, NJ, OR, PA and TX  No O.U.S.",
      "recall_number": "Z-1933-2024",
      "product_description": "RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3  Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.",
      "product_quantity": "7 systems",
      "reason_for_recall": "A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.",
      "recall_initiation_date": "20240416",
      "center_classification_date": "20240530",
      "report_date": "20240605",
      "code_info": "Model Number: RXM1000 UDI Codes that includes system serial numbers: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008",
      "more_code_info": ""
    }
  ]
}