FDA Device recall Z-1122-2017
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy by Mevion Medical Systems, citing an error can occur causing Delta corrections to be lost when one setup field is closed and another is opened.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1122-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-16 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mevion Medical Systems |
| Distribution | US |
Product
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Reason
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
Identifiers
| code_info | S250-0002 and S250-0003 |
|---|
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-1122-2017%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.