Brainlab ExacTrac Dynamic Software Recall: Incorrect Yaw Angle Risk
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.
Use caution until it’s fixed
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61034-brainlab-exactrac-dynamic-software-recall-incorrect-yaw-angle-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61034-brainlab-exactrac-dynamic-software-recall-incorrect-yaw-angle-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0733-2022
Cite this page
“Brainlab ExacTrac Dynamic Software Recall: Incorrect Yaw Angle Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61034-brainlab-exactrac-dynamic-software-recall-incorrect-yaw-angle-risk. Based on FDA recall #Z-0733-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0733-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Brainlab- Product
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and- Category
Medical device
What to do — step by step
Check Software Version
Verify your ExacTrac Dynamic software version is 1.0.0, 1.0.1, 1.0.2, or 1.0.3.
Contact Manufacturer
Reach out to Brainlab for guidance on whether your software needs updating or correction.
Where it went and when
Where it was distributed
Distributed in 20 states, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, California, Colorado, Florida, Georgia, Indiana, Kentucky, Maryland, Mississippi, Missouri, New Jersey, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0733-2022 (February 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0733-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.