FDA-Device2014-12-17Class II
MEVION S250, used for proton radiation therapy.
Mevion Medical Systems, Inc.
Hazard
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
Sold states
US Distribution in the state of MO
Affected count
1
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
MEVION S250, used for proton radiation therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0588-2015Don't want to check this manually?
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