Recall – Incorrect scanner positioning workflow

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.