{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "209112",
      "product_res_number": "Z-2413-2024",
      "event_date_initiated": "2021-10-28",
      "event_date_posted": "2024-08-12",
      "recall_status": "Open, Classified",
      "res_event_number": "95017",
      "product_code": "OAS",
      "k_numbers": [
        "K163423"
      ],
      "product_description": "Orthopantomograph OP300 dental computed tomography x-ray system.\n\nThe X-ray device produces conventional 2D X-ray images and Xray\nprojection images for the reconstruction of a 3D view. The device is operated and\nused by qualified healthcare professionals.",
      "code_info": "DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756,\n06430035872763, 06430035872770",
      "firm_fei_number": "3005383085",
      "recalling_firm": "Palodex Group Oy",
      "address_1": "Nahkelantie 160 160 nahkelantie",
      "city": "Tuusula",
      "country": "Finland",
      "additional_info_contact": "Erika Martin\n40-512 1967",
      "reason_for_recall": "It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within\nthe set acceptance criteria (repeatability within 4%).",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "Palodex Group Oy is preparing a Class IlIl field correction to update the firmware of\nORTHOPANTOMOGRAPH OP 3D Pro of the 27 defective units and these devices\nwill be retested for Pan ADC reproducibility. All affected persons will be notified of\nthis defect in accordance with 21 CFR 806.10.",
      "product_quantity": "103",
      "distribution_pattern": "US Nationwide-Worldwide",
      "openfda": {
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        "device_name": "X-Ray, Tomography, Computed, Dental",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1750",
        "device_class": "2"
      }
    }
  ]
}