FDA-Device2022-04-06Class II
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Mevion Medical Systems, Inc.
Hazard
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
Affected count
39 (36 US, 3 OUS)
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2022Don't want to check this manually?
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