{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Feldkirchen",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67719",
      "recalling_firm": "Brainlab AG",
      "address_1": "Kapellenstrasse 12",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France,  Germany, Japan, Netherlands, and the United Kingdom.",
      "recall_number": "Z-1513-2014",
      "product_description": "ExacTrac 6.0 is a patient positioning and monitoring system.    Model/catalogue numbers:  20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE  49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3  49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC  49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49973B ET DATA PREP / REVIEW SYSTEM  49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT  49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED",
      "product_quantity": "41 systems (13 systems in US; 28 systems to foreign countries)",
      "reason_for_recall": "When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point.  As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.",
      "recall_initiation_date": "20140224",
      "center_classification_date": "20140425",
      "termination_date": "20170424",
      "report_date": "20140507",
      "code_info": "ExacTrac version v.6.0.3.",
      "more_code_info": ""
    }
  ]
}