BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1582-2015 · Initiated March 6, 2015

    Recall

    Recall Number
    Z-1582-2015
    Event Number
    70951
    Firm
    Brainlab AG Kapellenstrasse 12 Feldkirchen Germany
    FEI Number
    3002619595
    Product Code
    IYH
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    March 6, 2015
    Posted
    May 6, 2015
    Terminated
    April 24, 2017

    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.

    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 [email protected].

    Distribution

    *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland

    Quantity

    25 systems (US only); 53 systems (Foreign)