medical Class II Updated 2022-04-06

Mevion Medical Systems, Inc. recalls Mevion S250 and S250i Proton Therapy Systems hand pendant (P

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
View official government recall

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