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Mevion Medical Systems, Inc. recalls Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Recalled April 6, 2022 · FDA recall Z-0827-2022 · Mevion Medical Systems
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. · FDA Class II
Units
39 (36 US, 3 OUS)
Sold at
Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
Description
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.
Product
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Manufacturer(s)
Mevion Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →