{
  "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": [
    {
      "status": "Terminated",
      "city": "Tustin",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69748",
      "recalling_firm": "Toshiba American Medical Systems Inc",
      "address_1": "2441 Michelle Dr",
      "address_2": "P.O. Box 2068",
      "postal_code": "92780-7047",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution to CA, MA, MD",
      "recall_number": "Z-0472-2015",
      "product_description": "Cardiac Function Analysis Software  Product Data No. MPDCT0301EAD  CSCF-003A    The software is applicable to the following CT systems:  Aquilion ONE TSX-301A/2D     X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation.  The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.",
      "product_quantity": "2 units within the U.S. only",
      "reason_for_recall": "Potential problem with the cardiac function analysis software (CFA).  Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.",
      "recall_initiation_date": "20141105",
      "center_classification_date": "20141126",
      "termination_date": "20151009",
      "report_date": "20141203",
      "code_info": "Item                          CFA Software Serial Number:           Description  TSX-301A/2D                  1BA07X2002                                  Aquilion One  TSX-301A/2D                  1BA07X2001                                  Aquilion One",
      "more_code_info": ""
    }
  ]
}