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.
The software error can cause the system display to incorrectly show that the patient is within safe positioning limits when they are actually outside those limits. This could allow the radiation treatment to proceed without proper safety checks, potentially exposing patients to unsafe radiation levels.
Medical facilities using ExacTrac Dynamic systems with software versions 1.0.0 through 1.0.2 are affected. Patients receiving radiation therapy with these systems may be at risk if the software error occurs during treatment.
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.
Verify your ExacTrac Dynamic system's software version to see if it is 1.0.0, 1.0.1, or 1.0.2.
Software versions 1.0.0, 1.0.1, and 1.0.2 are affected.
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.
The recall record does not specify a remedy, so you should contact Brainlab directly for guidance.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-1185-2021 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-1185-2021 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.
