Brainlab AG Olof-palme-str. 9 Munich Germany ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Brand
Brainlab AG Olof-palme-str. 9 Munich Germany
Lot Codes / Batch Numbers
1.0.1, 1.0.2.
Products Sold
Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2.
Brainlab AG Olof-palme-str. 9 Munich Germany is recalling ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The Field Safety Notice / Product Notification Letter CAPA-20210210-002387 was distributed via email on 03/01/2021. An active reply by the consignees will be followed, if necessary via further different communication media. For future customers/facilities/systems (new installations or updates/upgrades): As of February 23, 2021: - the Field Safety Notice / product notification information is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative, - a confirmation is required that the contained User Corrective Actions will be implemented before clinical use by the facility (to be adhered to by the users).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, IN, NJ, NY, NC, OR
Page updated: Jan 10, 2026