Events

Safety Alert for ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Brainlab AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-03-11
  • Event Date Posted
    2015-03-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150311a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: brainlab exactrac v. 6.X – cone beam computed tomography (cbct) import & alignment software medical device manufacturer, brainlab ag, has issued a medical device safety alert concerning its exactrac v. 6.X – cone beam computed tomography (cbct) import & alignment software [software version: 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), in combination with varian truebeam system only]. according to the manufacturer, if a user-defined actively re-reconstructed cbct subvolume is imported into exactrac, exactrac cannot regard the position of this cbct subvolume correctly. if the center of this subvolume differs from the center of the original cbct volume, this leads to an erroneous calculation of patient shifts needed to move the patient to the planned treatment position. if the corresponding calculated shifts and rotations are applied with exactrac, the patient will be positioned incorrectly at the linear accelerator (linac). if not detected by the user, the radiation treatment dose at the linac may be delivered to an unintended target position. if the deviation exceeds clinically acceptable limits, this could result in ineffective treatment, serious patient injury, or even death of the patient. the manufacturer advises users to take the following actions:- with immediate effect, do not use any actively re-reconstructed cbct subvolumes from the varian truebeam system with the brainlab exactrac 6.X cbct import & alignment software module. import exclusively original, not modified, cbct volumes into exactrac to use for patient positioning. continue to verify any exactrac cbct-based correction using the exactrac x-ray verification and/or an external igrt procedure as mandatory. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 march 2015.

Device

ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Brainlab ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG