{
  "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": "193856",
      "product_res_number": "Z-1404-2022",
      "event_date_initiated": "2022-04-27",
      "event_date_created": "2022-07-19",
      "recall_status": "Open, Classified",
      "res_event_number": "90231",
      "product_code": "JAD",
      "k_numbers": [
        "K172080"
      ],
      "product_description": "X80 RADiant Photoelectric Therapy System",
      "code_info": "Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008",
      "firm_fei_number": "3004561814",
      "recalling_firm": "Xstrahl Limited",
      "address_1": "Unit 2 Maybrook Industrial Estate Maybro Maybrook Road",
      "city": "Walsall",
      "country": "United Kingdom",
      "reason_for_recall": "There is a potential compatibility issue with the systems and replacement treatment applicators.",
      "root_cause_description": "Finished device change control",
      "action": "The firm sent out the recall notification on 04/27/2022 via email. The letter mentions the consignee is able to continue to use the system. The consignee is to ensure that the verification of selection of the correct applicator for the planned treatment is conducted with the consignee's procedures and radiotherapy professional practice and guidelines. They are asked to complete a response form and return it no later than 30 days.",
      "product_quantity": "7 devices; 70 treatment applicators",
      "distribution_pattern": "US Distribution FL, CA, KY",
      "openfda": {
        "k_number": [
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        "device_name": "System, Therapeutic, X-Ray",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5900",
        "device_class": "2"
      }
    }
  ]
}