{
  "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": "2026-09-08",
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      "date_changed": "20250810",
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            "No Code Available",
            "No Code Available"
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6503132",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
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      "mdr_text": [
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          "mdr_text_key": "73115483",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE BR16005 HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED."
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        },
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          "text_type_code": "Additional Manufacturer Narrative",
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          "text": "A NEW DESIGN ISSUE WAS DISCOVERED DURING THE INVESTIGATION OF A COMPLAINT, RELATED TO THE IMPROPER PROCESSING OF EXAM ACQUIRED WITH A GANTRY TILT IN THE SOFTWARE. A RETROSPECTIVE REVIEW OF THE COMPLAINTS RECEIVED PREVIOUSLY WAS PERFORMED. THE SUBJECT EVENT WAS INITIALLY IDENTIFIED TO BE DUE TO A USER ERROR (USE OF DIFFERENT SCANNING PROCEDURE THAT RESULTED IN DIFFERENTLY SCALED IMAGES). HOWEVER THE REVIEW OF THE AVAILABLE DATA CONFIRMED THAT THIS ROOT CAUSE WAS INCORRECT AND THAT THE EVENT IS DUE TO THE NEWLY IDENTIFIED DESIGN DEFECT."
        },
        {
          "mdr_text_key": "187138874",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DURING SURGERY, THE CT SCAN WAS LOADED ON THE DEVICE FROM AN USB DRIVE. ONCE OPENED ON THE DEVICE, THE IMAGES HAD AN INCORRECT APPEARANCE AND THE RESULT OF THE CT AND MRI AUTOMATIC MERGE WAS INCORRECT. TO BE ABLE TO PERFORM THE SURGERY, A NEW CT SCAN WAS ACQUIRED."
        },
        {
          "mdr_text_key": "130543769",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE ROOT CAUSE IS THAT THE RADIOLOGY DEPARTMENT IN THE HOSPITAL USED A DIFFERENT SCANNING PROCEDURE THAT RESULTED IN DIFFERENTLY SCALED IMAGES."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "08/02/2017;12/21/2018"
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}