{
  "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": "3",
      "code_info": "728323 -- Ingenuity Core128              320004 320053  320056",
      "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 Core128, Model number 728323    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-2658-2016",
      "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"
    }
  ]
}