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FDAMarch 15, 2016device

MEVION S250 for Proton Radiation Therapy

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

mevion medical systemsmevionmevion medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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MEVION S250 for Proton Radiation Therapy — Recall Details · AllClear