{
  "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": "Bothell",
      "state": "WA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71635",
      "recalling_firm": "EKOS Corporation",
      "address_1": "11911 N Creek Pkwy S",
      "address_2": "N/A",
      "postal_code": "98011-8809",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-2148-2015",
      "product_description": "The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device.    The EkoSonic Endovascular System consists of three main components:    -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and  -removable MicroSonic Device (MSD), and   -a reusable EKOS EkoSonic Control System.     During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site.     The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control.     A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.",
      "product_quantity": "46 units",
      "reason_for_recall": "The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.",
      "recall_initiation_date": "20150624",
      "center_classification_date": "20150720",
      "termination_date": "20150825",
      "report_date": "20150729",
      "code_info": "CIC Serial Numbers:    19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103,   19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112,   19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118,   19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127,   19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135,   19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144,   19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153,   19598-154, 19598-156, 19598-157, 19598-158."
    }
  ]
}