FDA Device recall Z-0705-2019
MEVION S250i
- FDA Device
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of MEVION S250i by Mevion Medical Systems, citing treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0705-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-01 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mevion Medical Systems |
| Distribution | DC |
Product
MEVION S250i
Reason
Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
Identifiers
| code_info | DI: (01)00864366000124 Serial Number: S250i-0007 |
|---|
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-0705-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.