Events

Recall of Device Recall ExacTrac 6.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brainlab AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67719
  • Event Risk Class
    Class 2
  • Event Number
    Z-1513-2014
  • Event Initiated Date
    2014-02-24
  • Event Date Posted
    2014-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126143
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    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.
  • Action
    A FIELD SAFETY NOTICE / PRODUCT INFORMATION letters, dated February 24, 2014, were sent to all direct accounts. The letter identified the affected product, the reason for the recall, and included instructions for direct accounts to take while a permanent fix can be deployed. The letter also advised that a software update will be made available starting the end of April 2014. Customers with questions or concerns can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall ExacTrac 6.0
  • Model / Serial
    ExacTrac version v.6.0.3.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • 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
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    USFDA