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Mevion Medical Systems, Inc. recalls MEVION S250 for Proton Radiation Therapy
Recalled April 27, 2016 · FDA recall Z-1529-2016 · Mevion Medical Systems
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. · FDA Class II
Units
5
Sold at
US nationwide distribution to MO, OK, FL, and NJ.
Description
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.
Product
MEVION S250 for Proton Radiation Therapy
Manufacturer(s)
Mevion Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →