{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218900",
      "product_res_number": "Z-1949-2026",
      "event_date_initiated": "2026-03-23",
      "event_date_posted": "2026-04-24",
      "recall_status": "Open, Classified",
      "res_event_number": "98487",
      "product_code": "QYV",
      "product_description": "Brand Name: Genius\" Review Station\nProduct Name: Genius\" Review Station Display (Barco Monitor)\nModel/Catalog Number: CMP-01669\nSoftware Version: N/A - not software version specific\nComponent: Yes, the Genius\" Review Station is a component of the Genius\" Digital Diagnostics System with the Genius\" Cervical AI Algorithm cleared under DEN210035.",
      "code_info": "Model Number: CMP-01669;\nUDI-DI: 15420045514201;\nSerial Number: All;",
      "firm_fei_number": "1000120743",
      "recalling_firm": "Hologic, Inc",
      "address_1": "250 Campus Dr",
      "city": "Marlborough",
      "state": "MA",
      "postal_code": "01752-3020",
      "additional_info_contact": "ThinPrep Technical Support\n+1-800-4429892 Ext. 1",
      "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.",
      "root_cause_description": "Software design",
      "action": "On March 23, 2026, Urgent Medical Device Recall letters were sent to customers.\nActions to be taken:\nIf you are receiving this notification, our records indicate that you have received a Genius\" Review Station\nMonitor (CMP-01669). As this field correction applies to all monitors, please follow the instructions below and\ncomplete the Customer Response Form (CRF) using the link or QR code provided below. If you are a\ndistributor or otherwise supply Genius\" Review Station Monitors to downstream customers, you are responsible for promptly forwarding this notification to all affected sub-accounts and ensuring completion of the\nCRF for each end-user site.\nDo not change monitor settings\n\" Continue to use the Genius\" Review Station only with the original monitor settings configured by\nHologic at installation.\n\" Do not:\n\" Disable Barco Application Appearance Manager (AAM)\n\" Change Barco QAWeb calibration or compliance test settings\n\" Adjust or otherwise modify the monitor configuration parameters outside of the original\nconfiguration by Hologic at installation.\n\" Only Hologic, or its authorized provider may modify Genius\" Review Station monitor configuration\nsettings.\nIf monitor settings have been altered\n\" If you are aware that monitor display or calibration settings have been changed from the original\nconfiguration, do not use the Genius\" Review Station monitor for clinical review until the\nmonitor has been returned to the original configuration by Hologic or its authorized service\nprovider.\n\" Complete the Customer Response Form (CRF) so Hologic and its field service partner, IQVIA\nMedTech, can coordinate restoration of the approved configuration.\nPlease promptly fill out the Customer Response Form (CRF) to acknowledge you have received this\nnotification. Distributors should ensure that all downstream customers complete the CRF or provide the required\ninformation on their behalf.",
      "product_quantity": "1200 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide  and the countries of Asia Pacific, Europe, and the Middle East.",
      "openfda": {
        "k_number": [
          "DEN210035"
        ],
        "device_name": "Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm",
        "medical_specialty_description": "Pathology",
        "regulation_number": "864.3900",
        "device_class": "2",
        "registration_number": [
          "3006330030",
          "1222780"
        ],
        "fei_number": [
          "3006330030",
          "1000120743"
        ]
      }
    }
  ]
}