Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Reason: 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.

Code information: All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.

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