{
  "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": "2026-08-05",
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      "date_changed": "20250728",
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      "date_manufacturer_received": "20080207",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "N",
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      "mdr_text": [
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          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A CUSTOMER REPORTED THAT A PATIENT BEING TREATED FOR LUNG CANCER HAD BEEN TREATED FOR 5 FRACTIONS WITH AN INCORRECT ISOCENTER (5 CM ERROR). THE ISOCENTER ERROR WAS INTRODUCED BY AN IMPORT APPLICATION PROBLEM IN FOCAL. HOWEVER, THE ERROR IS HIGHLY DETECTABLE AND IN THIS CASE, THE XIO VISUAL DISPLAY CLEARLY ALERTED DOSIMETRY TO THE PROBLEM. BASED ON CUSTOMER INPUT, THE INFORMATION LEAVING DOSIMETRY TO THE TREATMENT ROOM WAS CORRECT, BUT ADDITIONAL USER ERRORS SEEMED TO CAUSE THE ACTUAL MISTREATMENT. CLINICIANS ADJUSTED THE REMAINING FRACTIONS TO COMPENSATE. THE IMPORT APPLICATION PROBLEM WAS INTRODUCED IN FOCAL 4.3.0 AND CORRECTED IN FOCAL 4.34."
        },
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          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "A CUSTOMER ADVISORY IS BEING DRAFTED FOR TRANSMITTAL TO ALL CUSTOMERS OF OUR FOCAL WORKSTATION TO ADVISE THEM OF THIS SITUATION."
        }
      ],
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}