{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Cleveland",
      "address_1": "595 Miner Rd",
      "reason_for_recall": "After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.",
      "address_2": "",
      "product_quantity": "30",
      "code_info": "728321 -- Ingenuity Core        310004 310005 310012 310016 310020 310021 310027 310028 310033 310034 310041 310044 310045 310057 310061 310065 310072 310074 310076 310077 310078 310094 310099 310100 310103 310105 310117 310120 310122 310135",
      "center_classification_date": "20160825",
      "distribution_pattern": "US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY",
      "state": "OH",
      "product_description": "Ingenuity Core, Model number 728321    Product Usage:  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.",
      "report_date": "20160831",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Philips Medical Systems (Cleveland) Inc",
      "recall_number": "Z-2657-2016",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "74820",
      "termination_date": "20180702",
      "more_code_info": "",
      "recall_initiation_date": "20160720",
      "postal_code": "44143-2131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}