Brainlab recalls ExacTrac Dynamic software versions 1.0.0-1.0.3 for potential incorrect yaw angle during CBCT positioning with Varian LINACs. Affected units include specific model numbers and GTIN.
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Brainlab is recalling ExacTrac Dynamic software versions 1.0.0 through 1.0.3 due to a potential incorrect yaw angle measurement during certain radiation therapy setups. This could lead to misalignment of treatment beams if used with Varian LINACs.
The software may provide an incorrect yaw angle measurement during CBCT (computed tomography) positioning workflows when used with Varian LINACs. This could cause the radiation beam to be misaligned with the patient's body, potentially affecting treatment accuracy.
Radiation therapy patients and medical staff using the ExacTrac Dynamic software with Varian LINACs are most at risk. Affected units include specific model numbers and software versions listed in the recall.
Check if your ExacTrac Dynamic software is version 1.0.0, 1.0.1, 1.0.2, or 1.0.3. Affected units have model numbers 20910-01, 20910-01A, 20910-01B, or 20910-01C and GTIN 04056481142315.
Verify your ExacTrac Dynamic software version is 1.0.0, 1.0.1, 1.0.2, or 1.0.3.
Reach out to Brainlab for guidance on whether your software needs updating or correction.
Software versions 1.0.0, 1.0.1, 1.0.2, and 1.0.3 are affected.
The software may provide an incorrect yaw angle measurement during CBCT positioning with Varian LINACs, potentially causing misalignment of the radiation beam.
Check for model numbers 20910-01, 20910-01A, 20910-01B, or 20910-01C and software versions 1.0.0 through 1.0.3 with GTIN 04056481142315.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0733-2022 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-0733-2022 from Brainlab. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
