{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Feldkirchen",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71248",
      "recalling_firm": "Brainlab AG",
      "address_1": "Kapellenstrasse 12",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed in the US and Australia.",
      "recall_number": "Z-0282-2016",
      "product_description": "BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial  ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1  An intraoperative image-guided localization system to enable minimally invasive surgery.",
      "product_quantity": "12 systems total (10 in U.S., 2 in Australia)",
      "reason_for_recall": "Instances of data sets not being accurately registered to the patient anatomy were observed.",
      "recall_initiation_date": "20150508",
      "center_classification_date": "20151117",
      "termination_date": "20170228",
      "report_date": "20151125",
      "code_info": "Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM;  19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL.       Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1)"
    }
  ]
}