FDA Device recall Z-0411-2017
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 software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0411-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-20 |
| 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
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
Identifiers
| code_info | Serial Numbers: 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-0411-2017%22
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