Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- February 1, 2022
- Recall Number
- Z-0827-2022
- Quantity
- 39 (36 US, 3 OUS)
- Firm Location
- Littleton, MA
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
Lot / Code Info
All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Root Cause
Component design/selection
Action Taken
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.