FDA Device recall Z-0410-2017
MEVION S250 Product Usage: Proton Radiation Therapy System
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of MEVION S250 Product Usage: Proton Radiation Therapy System by Mevion Medical Systems, citing recovery of Incorrect Isocenter -operational change.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0410-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-21 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mevion Medical Systems |
| Distribution | US |
Product
MEVION S250 Product Usage: Proton Radiation Therapy System
Reason
Recovery of Incorrect Isocenter -operational change
Identifiers
| code_info | Serial Number: S250-0001 through S250-0006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0410-2017%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.