{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Belgrade",
      "state": "",
      "country": "",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79848",
      "recalling_firm": "Visaris DOO",
      "address_1": "Batajnicki Drum 10 Deo 1B",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the states of : FL, LA, MD, MS, NJ, and NY., and to the countries of :  Czech Republic, Germany, Serbia, Switzerland, Taiwan, and United Kingdom.",
      "recall_number": "Z-1881-2018",
      "product_description": "Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3  The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics",
      "product_quantity": "8 devices (US), 14 devices (international)",
      "reason_for_recall": "A failure of the tube arm suspension is possible while the tube arm height is being adjusted.  During tube height adjustment there is a small probability of failure of both the primary and redundant holding mechanisms, causing uncontrollable descent of the tube arm and a potential risk of injury to the patient.",
      "recall_initiation_date": "20180405",
      "center_classification_date": "20180515",
      "termination_date": "20190919",
      "report_date": "20180523",
      "code_info": "US Systems:  System SN VC16J-01002, Column SN BA-215-1800-862-1-3 0022;  System SN VC16F-04002, Column SN BA-215-1800-862-1-3 0026;  System SN VC16E-02002, Column SN BA-215-1500-792-1 0004;  System SN VC16E-01002, Column SN BA-215-1500-792-1 0003;  System SN VC15K-01002, Column SN BA-215-1500-792-1 0002;    International Systems:  System SN VC16H-01002, Column SN BA-215-1500-792-1 0007;  System SN VC16F-03002, Column SN BA-215-1800-862-1-3 0007;  System SN VC16F-01002, Column SN BA-215-1500-792-1 0004;  System SN VC16F-02002, Column SN BA-215-1800-862-1-3 0012;",
      "more_code_info": ""
    }
  ]
}