Recall Z-0827-2022 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
| Date | Feb 1, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 39 (36 US, 3 OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands. |
| FDA record | Open on fda.gov |