medical Class II Updated 2021-03-17

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

Affected States: CA, NJ, AZ, AR, NY, IN, OR, NC
Lot/Code Info: 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.
View official government recall

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