{
  "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": "Brisbane",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88101",
      "recalling_firm": "Caption Health",
      "address_1": "2000 Sierra Point Pkwy Fl 8",
      "address_2": "N/A",
      "postal_code": "94005-1845",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US : AZ, DE, NY, IL, CT  OUS: None",
      "recall_number": "Z-2111-2021",
      "product_description": "Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)",
      "product_quantity": "15 systems",
      "reason_for_recall": "The firm is aware of a issue  with  ultrasound software that results in unintended video frames being included.  This could lead to an incorrect automated ejection  fraction (AutoEF) and image quality score (IQS) estimates.",
      "recall_initiation_date": "20210519",
      "center_classification_date": "20210722",
      "termination_date": "20230131",
      "report_date": "20210728",
      "code_info": "All product  containing software version 1.2.0",
      "more_code_info": ""
    }
  ]
}