FDA recall Z-0827-2022

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-02-01

Report date

2022-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Littleton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2022