Company:BRAINLAB AG
Date of Enforcement Report 12/6/2017
Class lI:
PRODUCT
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd.
Recall Number Z-0172-2018
REASON
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed. .
RECALLING FIRM/MANUFACTURER
BRAINLAB AG, MUnich Germanyon 11/3/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
28
DISTRIBUTION
Nationwide and Internationally
___________________________________
