{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Shanghai",
      "state": "N/A",
      "country": "China",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85453",
      "recalling_firm": "Shanghai United Imaging Healthcare Co., Ltd.",
      "address_1": "No. 2258 Chengbei Rd, Jiading Ind.",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the state of TX.",
      "recall_number": "Z-2819-2020",
      "product_description": "Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.",
      "product_quantity": "3",
      "reason_for_recall": "In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.",
      "recall_initiation_date": "20200326",
      "center_classification_date": "20200818",
      "termination_date": "20230802",
      "report_date": "20200826",
      "code_info": "UDI: 06971576832026,  Software Version: R001.3.0.0.750505,  Serial Numbers:  200017,  200023,  200024"
    }
  ]
}