FDA-Device2016-04-27Class II
MEVION S250 for Proton Radiation Therapy
Mevion Medical Systems, Inc.
Hazard
Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.
Sold states
US nationwide distribution to MO, OK, FL, and NJ.
Affected count
5
Manufactured in
300 Foster Street, N/A, Littleton, MA, United States
Products
MEVION S250 for Proton Radiation Therapy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2016Don't want to check this manually?
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