{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cleveland",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63817",
      "recalling_firm": "Philips Medical Systems (Cleveland) Inc",
      "address_1": "595 Miner Rd",
      "address_2": "N/A",
      "postal_code": "44143-2131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.",
      "recall_number": "Z-0674-2013",
      "product_description": "Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems:  Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.",
      "product_quantity": "A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)",
      "reason_for_recall": "Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems.  If these  issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.",
      "recall_initiation_date": "20121203",
      "center_classification_date": "20130115",
      "termination_date": "20130618",
      "report_date": "20130123",
      "code_info": "Brilliance CT X-RAY System - Model/System Code #728231,  Serial Number distributed in the U.S. was:   9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were:  300018, and 300003. The remaining Serial Numbers distributed overseas were:  91003, 95130, 95157, 95504, and Serial Numbers:  300010,  and 300030 ."
    }
  ]
}