Events

Recall of Device Recall Brainlab ExacTrac 6.x Patient Positioning System

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
    70951
  • Event Risk Class
    Class 2
  • Event Number
    Z-1582-2015
  • Event Initiated Date
    2015-03-06
  • Event Date Posted
    2015-05-06
  • 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=135814
  • 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
    Generator, dermatological (grenz ray), therapeutic x-ray - Product Code IYH
  • Reason
    Exactrac 6.X patient positioning system: potentially incorrect patient positioning when using the exactrac cone beam ct (cbct) with a cbct acquired at a couch angle other than 0.0 degrees.
  • Action
    FIELD SAFETY / PRODUCT NOTIFICATION letters dated March 6, 2015 were sent to all customers of record. The letters included instructions for customers to: 1) With immediate effect, always make sure the couch is at exactly 0.0 degrees (displayed on the Varian monitor) when acquiring a CBCT set to import into the ExacTrac software; 2) For Varian systems providing an option to prevent a CBCT acquisition for couch angles other than 0.0 degrees, Brainlab recommends selecting that option for use in combination with ExacTrac; and, 3) Continue to verify any ExacTrac CBCT based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. The letters further advised that Brainlab will be taking the following actions: 1. Brainlab provides existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian C-Series linac) with this product notification information; and, 2. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customers starting August 2015 to schedule the update installation. Customers with questions about this issue were advised to contact Brainlab at 800-597-5911 or via e-mail by writing at us.support@brainlab.com.

Device

Device Recall Brainlab ExacTrac 6.x Patient Positioning System
  • Model / Serial
    Software Versions: ExacTrac v. 6.x (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0);   Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE;  48320, ET UPGRADE SOFTWARE 6.0 TO 6.1;  48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA;  49973B, ET DATA PREP / REVIEW SYSTEM;  49973A, ET DATA PREP / REVIEW SYSTEM;  49973, ET DATA PREP / REVIEW SYSTEM;  49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT;  48302, ET DATA PREP / REVIEW SYSTEM
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland
  • Product Description
    ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
  • Manufacturer
    Brainlab AG

Manufacturer

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