{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98487",
      "recalling_firm": "Hologic, Inc",
      "address_1": "250 Campus Dr",
      "address_2": "",
      "postal_code": "01752-3020",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide  and the countries of Asia Pacific, Europe, and the Middle East.",
      "recall_number": "Z-1949-2026",
      "product_description": "Brand Name: Genius\" Review Station  Product Name: Genius\" Review Station Display (Barco Monitor)  Model/Catalog Number: CMP-01669  Software Version: N/A - not software version specific  Component: Yes, the Genius\" Review Station is a component of the Genius\" Digital Diagnostics System with the Genius\" Cervical AI Algorithm cleared under DEN210035.",
      "product_quantity": "1200 units",
      "reason_for_recall": "It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.",
      "recall_initiation_date": "20260323",
      "center_classification_date": "20260424",
      "report_date": "20260506",
      "code_info": "Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;",
      "more_code_info": ""
    }
  ]
}