{
  "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": "Munich",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86438",
      "recalling_firm": "Brainlab AG",
      "address_1": "Olof-palme-str. 9",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerland, Netherlands, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kuwait, Malaysia, Myanmar, Norway, Pakistan, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey and United Kingdom.",
      "recall_number": "Z-0056-2021",
      "product_description": "Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage:  intended to be an intra-operative image guided localization system to enable minimally invasive surgery.",
      "product_quantity": "271 units",
      "reason_for_recall": "Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.",
      "recall_initiation_date": "20200831",
      "center_classification_date": "20201006",
      "termination_date": "20210217",
      "report_date": "20201014",
      "code_info": "Model/catalogue numbers:  22582 IGSONIC BK MEDICAL SOFTWARE  22582A ULTRASOUND INTEGRATION SW (BK)  22582B ULTRASOUND INTEGRATION SW  22583 LICENSE UPDATE TO IGSONIC SW FOR BK MED  26506 ULTRASOUND SW BK800 SUBSCRIPTION  26506A ULTRASOUND SW BK SUBSCRIPTION  26508A ULTRASOUND SW BK UPDATE    UDI:  The GTIN for Ultrasound Navigation 1.0 is: 04056481140137  The GTIN for Cranial/ENT Navigation 3.1 is: 04056481132439"
    }
  ]
}