{
  "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": [
    {
      "country": "United States",
      "city": "Tustin",
      "address_1": "2441 Michelle Dr",
      "reason_for_recall": "The systems all have a similar table control board. It has  been found that this board may cause the table position to be incorrect if the table cradle is moved  manually. This is referred to as \"Free\" mode in the operation manuals. If this error does occur it is  possible that the patient could be scanned at an incorrect position.",
      "address_2": "P.O. Box 2068",
      "product_quantity": "757",
      "code_info": "Serial Number Range (last 4): (2665-3149), (2211-2237), (2057-2067), A3622041, A4582122 + (2690-3131), (2001-2171), (2001-2124), (2001-2255), (2001-3007), (2015-2061), (2001-2008).    The following Device Name/Model Number:  Asteion Super 4 / TSX-021B  Aquilion Super 4 / TSX-101A/7  Aquilion 8 / TSX-101A/F  Aqui1ion 16/ TSX-101A/6  Aqui1ion 16/ TSX-101A/G  Aquilion 32 / TSX-101A/D  Aquilion 32 / TSX-101A/I  Aquilion 64/TSX-101A/E  Aquilion 64 / TSX-101AIH  Aquilion 16 LB / TSX-201A  AquilionONE / TSX-301A",
      "center_classification_date": "20120824",
      "distribution_pattern": "USA ( Nationwide Distribution )",
      "state": "CA",
      "product_description": "Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase.     This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.",
      "report_date": "20120905",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Toshiba American Medical Systems Inc",
      "recall_number": "Z-2266-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62851",
      "termination_date": "20120904",
      "recall_initiation_date": "20080227",
      "postal_code": "92780-7047",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}