Brainlab recalls ExacTrac Dynamic radiation therapy systems with software versions 1.0.0-1.0.2 due to potential unsafe patient positioning during treatment. Affected units may allow treatment to proceed when patient is out of safe range.
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
Brainlab is recalling ExacTrac Dynamic radiation therapy systems with specific software versions because a software error could cause the system to allow treatment to proceed when the patient is actually outside safe positioning limits. This could lead to unsafe radiation exposure if the system incorrectly shows the patient is within acceptable positioning tolerances. Read more at govinfonow.com/recall/63182-brainlab-exactrac-dynamic-software-error-risks-unsafe-radiation-treatment.
“Brainlab ExacTrac Dynamic: Software error risks unsafe radiation treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63182-brainlab-exactrac-dynamic-software-error-risks-unsafe-radiation-treatment. Based on FDA recall #Z-1185-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1185-2021%22&limit=1).
Brainlab AG voluntarily recalled the ExacTrac Dynamic Medical Charged-Particle Radiation Therapy System on March 1, 2021, according to the FDA. A software error may cause display parts to incorrectly indicate patient position within tolerances, potentially allowing treatment despite exceeding shift values.
A failed automatic marker detection causes a software error where parts of the display incorrectly behave as if the current patient position is within predefined tolerances. This may allow the user to proceed to treatment despite potentially exceeding shift values.
Context
GovInfoNow's records show Brainlab AG has 15 other recalls on record since July 28, 2017. Other recent recalls of similar products include Brainlab Origin Data Management Software Recalled (2025-02-10), Brainlab Cirq Arm System 2.0 Recall (2023-03-02), and Brainlab ExacTrac Software Recall (2023-02-14). Other recent recalls of similar products include Hitachi Proton Beam Therapy System Recall (2026-02-06) and RayStation/RayPlan Software Recall (2025-11-28).
How to tell if you have this one
Check if your ExacTrac Dynamic system has software versions 1.0.0, 1.0.1, or 1.0.2. The system model number is 20910-06 ETD Implanted lic. and the GTIN is 04056481142315.
Brand
Brainlab
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your ExacTrac Dynamic system's software version to see if it is 1.0.0, 1.0.1, or 1.0.2.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, California, Indiana, New Jersey, New York, North Carolina, Oregon.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1185-2021 (March 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1185-2021 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.