{
  "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": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68741",
      "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": "Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.",
      "recall_number": "Z-2146-2014",
      "product_description": "ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.",
      "product_quantity": "15 systems",
      "reason_for_recall": "When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green \"OK\" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.",
      "recall_initiation_date": "20140624",
      "center_classification_date": "20140804",
      "termination_date": "20170424",
      "report_date": "20140813",
      "code_info": "ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE;   2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE;   3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE;   4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE;   5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR);   6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR);   7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR);   8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED;   9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC;   10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4;   11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4;   12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R;   13) 49973B ET DATA PREP / REVIEW SYSTEM;   14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY;   15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED;   16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT"
    }
  ]
}