FDA-Device2021-03-17Class II
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Brainlab AG
Hazard
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.
Sold states
USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.
Affected count
73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Manufactured in
Olof-palme-str. 9, Munich, Germany
Products
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2021Don't want to check this manually?
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