FDA-Device2023-03-22Class II
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Brainlab AG
Hazard
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Sold states
US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution.
Affected count
56 systems in the U.S.
Manufactured in
Olof-palme-str. 9, N/A, Munich, N/A, Germany
Products
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1259-2023Don't want to check this manually?
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