Brainlab AG: Medical Device Recall in 2015 - (Recall #: Z-1316-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..

Product Classification:

Class II

Date Initiated: February 16, 2015

Date Posted: April 1, 2015

Recall Number: Z-1316-2015

Event ID: 70657

Reason for Recall:

The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.

Status: Terminated

Product Quantity: 24 systems (US); 36 systems (Foreign)

Code Information:

ExacTrac versions 6.x including versions 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; The software may be contained in configured items: 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

Distribution Pattern:

Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated