Company: Mevion Medical Systems, Inc..
Date of Enforcement Report 12/17/2014
Class lI:
PRODUCT
MEVION S250, used for proton radiation therapy.
Recall Number Z-0588-2015
REASON
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%.
RECALLING FIRM/MANUFACTURER
Mevion Medical Systems, Inc., Littleton, MA 11/10/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
US Distribution in the state of MO
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