Brainlab AG recalls ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy
Recalled Product
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Hazard / Issue
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.
Issued by
FDA
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