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.
Check against the official notice below — it lists the full affected range.
Brainlab AG has recalled ExacTrac Dynamic software (model numbers 20910-01, 20910-01A, and 20910-01B, software versions 1.0.0, 1.0.1, and 1.0.2) because the yaw angle may be incorrect when used for CBCT positioning workflows with setup beams on Varian LINACs. A total of 205 systems were distributed across 20 U.S. states and 24 countries internationally, including Australia, Canada, China, France, Germany, Japan, and the United Kingdom.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Reason for recall: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. Distribution: Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, Quantity: 205 systems Lot/code info: Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.