Company: Brainlab AG
Date of Enforcement Report: 3/16/2022
Class II
PRODUCT
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
Recall Number:
Z-0733-2022
REASON
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
RECALLING FIRM/MANUFACTURER
Brainlab AG on 5/26/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
205 systems
DISTRIBUTION
U.S. Nationwide and International