Mevion Medical Systems, Inc. recalls Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Recall date

February 1, 2022

Source

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

Recall number

Z-0827-2022

FDA classification

Class II

Brand / firm

Mevion Medical Systems, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.

Why it was recalled

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

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 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)