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Mevion Medical Systems, Inc. Recall 89758

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

Mevion Medical Systems, Inc. Recall 89758 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0827-2022
Event ID89758
Event DescriptionMevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
Quantity39 (36 US, 3 OUS)
Recall ReasonMalfunction 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.
Device Classification20220406
Device Code InfoAll theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Center Classification Date20220325
Recall Initiation Date20220201
Recalling FirmMevion Medical Systems, Inc.
Initial Notification Visit
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