{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Torrance",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80067",
      "recalling_firm": "Shimadzu Medical Systems",
      "address_1": "20101 S Vermont Ave",
      "address_2": "N/A",
      "postal_code": "90502-1328",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.",
      "recall_number": "Z-2060-2018",
      "product_description": "Sonialvision Safire II, Model #: DAR-8000f     Product Usage:  This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.",
      "product_quantity": "17",
      "reason_for_recall": "When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the  pulse rate using a temporary edit function) it was observed the indicated \"irradiation time\" on the X-ray  Generator Console, as well as the \"integral dose\" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.",
      "recall_initiation_date": "20180112",
      "center_classification_date": "20180614",
      "termination_date": "20220224",
      "report_date": "20180620",
      "code_info": "Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002"
    }
  ]
}