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Mevion Medical Systems, Inc. recalls MEVION S250, used for proton radiation therapy.
Recalled December 17, 2014 · FDA recall Z-0588-2015 · Mevion Medical Systems
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%. · FDA Class II
Units
1
Sold at
US Distribution in the state of MO
Description
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%.
Product
MEVION S250, used for proton radiation therapy.
Manufacturer(s)
Mevion Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →