Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model recall — FDA Z-1259-2023
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Overview of recall records associated with Brainlab AG, including dates, categories and classifications where available.
Classification mix: Class II: 6.
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Display of potential patient movement might be delayed to the user for high dose treatments.
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…
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Holding force of the Positioning Arm can be reduced by prolonged non-use.
This page summarizes recall records in which the official source identifies Brainlab AG as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.