{
  "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": "Munich",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78488",
      "recalling_firm": "Brainlab AG",
      "address_1": "Olof-Palme-Strasse 9",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Distribution and to the countries of :  Belgium, Canada, France, Germany, Italy, Japan and  S. Korea",
      "recall_number": "Z-0172-2018",
      "product_description": "BRAINLAB EXACTRAC VERO, Model/Catalog Numbers:  46228 EXACTRAC VERO 3.5   46238 EXACTRAC VERO 3.5   46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3  46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4    The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.",
      "product_quantity": "28 units",
      "reason_for_recall": "Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift.  This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.",
      "recall_initiation_date": "20171103",
      "center_classification_date": "20171128",
      "termination_date": "20201214",
      "report_date": "20171206",
      "code_info": "Potentially affected are ExacTrac Vero versions 3.x. Currently only ExacTrac Vero SW versions 3.5(.x) are installed  for use on existing ExacTrac Vero Systems (only ExacTrac Vero v.3.5 exist in the field).  UDI:  04056481132446"
    }
  ]
}