Mevion Medical Systems, Inc. Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Brand
Mevion Medical Systems, Inc.
Lot Codes / Batch Numbers
All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Products Sold
All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Mevion Medical Systems, Inc. is recalling Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) due to Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Mevion has voluntarily recalled Hand Pendants for S250 and S250i Proton Therapy Systems. All distributed Hand Pendants have been inspected for the identified defect and those that failed inspection have been removed from service following technical service bulletin TSB0048. Subsequent Urgent Medical Device Recall Notice dated 02/11/2022 was hand delivered by on-site field service engineers. Customers are instructed to complete and return the acknowledgement receipt. Please contact Mevion Customer service (robyn.walker@mevion.com) with any questions or concerns.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026