medical Class II Updated 2022-03-16

Brainlab AG recalls ExacTrac Dynamic software model numbers: 20910-01, ETD Po

Recalled 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.

Hazard / Issue

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Issued by

FDA

Affected States: AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, WA
Lot/Code Info: Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.
View official government recall

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