Events

Recall of ExacTrac

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
    67926
  • Event Risk Class
    Class 2
  • Event Number
    Z-1707-2014
  • Event Initiated Date
    2014-04-15
  • Event Date Posted
    2014-06-03
  • 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=126619
  • 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 a specific plan update workflow in combination with a non-brainlab treatment planning system (tps), there is a possibility in exactrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
  • Action
    Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months. Customers with any questions about this issue can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

ExacTrac
  • Model / Serial
    ExacTrac software version 5.5.5 is included in the following model / catalog numbers:   1) 20818B ET SOFTWARE 5.5.5;  2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5;  3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5;  4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5;  5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5;  6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5;  7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5;  8) 49660A ET INFRARED SOFTWARE 5.5.5;  9) 49961 ET DATA PREP/REVIEW SYSTEM;  10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT;  11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT;  12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT;  13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT;  14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT;  15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
  • Product Description
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
  • Manufacturer
    Brainlab AG

Manufacturer

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