{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89020",
      "recalling_firm": "Philips Healthcare",
      "address_1": "3000 Minuteman Rd",
      "address_2": "",
      "postal_code": "01810-1032",
      "voluntary_mandated": "FDA Mandated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution",
      "recall_number": "Z-0238-2022",
      "product_description": "Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)",
      "product_quantity": "226 units",
      "reason_for_recall": "3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or  landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction.  Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at  0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.",
      "recall_initiation_date": "20210924",
      "center_classification_date": "20211124",
      "report_date": "20211201",
      "code_info": "Azurion 2.1(L1) and 2.1(L2)",
      "more_code_info": ""
    }
  ]
}