Mevion Medical Systems, Inc. recalls MEVION S250 for Proton Radiation Therapy

Recall date

March 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1529-2016

FDA classification

Class II

Brand / firm

Mevion Medical Systems, Inc.

Sold / distributed

US nationwide distribution to MO, OK, FL, and NJ.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEVION S250 for Proton Radiation Therapy