Company:Brainlab AG
Date of Enforcement Report: 9/2/2015
Class lI:

PRODUCT

ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Recall Number Z-2440-2015

REASON
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.

RECALLING FIRM/MANUFACTURER
Brainlab AG on 8/7/2015, Feldkirchen, DE on 8/5/2015. Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
361 systems

DISTRIBUTION
Nationwide and Internationally

___________________________________