FDA Device recall Z-0827-2022
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- FDA Device
- Class II
- ongoing
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) by Mevion Medical Systems, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-01 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mevion Medical Systems |
| Distribution | US |
Product
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
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.
Identifiers
| code_info | All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2022%22
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