{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Herlev",
      "state": "",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74691",
      "recalling_firm": "B-K Medical A/S",
      "address_1": "Mileparken 34",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US to TX, FL, and MA.  Internationally to Australia",
      "recall_number": "Z-2325-2016",
      "product_description": "BK Medical ApS Ultrasound System Scanner bk2300 -  Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2.  The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN",
      "product_quantity": "6",
      "reason_for_recall": "In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be  unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of  the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the  software.",
      "recall_initiation_date": "20160628",
      "center_classification_date": "20160803",
      "termination_date": "20160829",
      "report_date": "20160810",
      "code_info": "Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277",
      "more_code_info": ""
    }
  ]
}