Company: Mevion Medical Systems, Inc..
Date of Enforcement Report 2/8/2017
Class lI:
PRODUCT
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Recall Number Z-1122-2017
REASON
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
RECALLING FIRM/MANUFACTURER
Mevion Medical Systems, Inc., Littleton, MA on 12/16/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
US Nationwide in the states of OK, NJ
___________________________________
