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Brainlab AG recalls Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Recalled March 22, 2023 · FDA recall Z-1259-2023 · Brainlab AG
Hazard
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template · FDA Class II
Units
56 systems in the U.S.
Sold at
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.
Description
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Product
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →