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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0827-2022 |
Event ID | 89758 |
Event Description | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands. |
Quantity | 39 (36 US, 3 OUS) |
Recall Reason | 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. |
Device Classification | 20220406 |
Device Code Info | All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124. |
Center Classification Date | 20220325 |
Recall Initiation Date | 20220201 |
Recalling Firm | Mevion Medical Systems, Inc. |
Initial Notification | Visit |
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