{
  "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,
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  "results": [
    {
      "status": "Terminated",
      "city": "Shanghai",
      "state": "",
      "country": "China",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85340",
      "recalling_firm": "Shanghai United Imaging Healthcare Co., Ltd.",
      "address_1": "No. 2258 Chengbei Rd, Jiading Ind.",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state TX.",
      "recall_number": "Z-1708-2020",
      "product_description": "Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197,  UDI: (01)06971576832026 - 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": "2 units",
      "reason_for_recall": "Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.",
      "recall_initiation_date": "20190826",
      "center_classification_date": "20200415",
      "termination_date": "20220518",
      "report_date": "20200422",
      "code_info": "Serial Numbers: 200017 and 200023",
      "more_code_info": ""
    }
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}