FDA Device recall Z-0485-2021
MEVION S250i, MEVION S250
- FDA Device
- Class II
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class II recall of MEVION S250i, MEVION S250 by Mevion Medical Systems, citing treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0485-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-19 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mevion Medical Systems |
| Distribution | US |
Product
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Reason
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Identifiers
| code_info | Serial Numbers: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-…Serial Numbers: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: 01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0485-2021%22
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