FDA Device recall Z-1271-2014
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- FDA Device
- Class II
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class II recall of MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy by Mevion Medical Systems, citing geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1271-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-05 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mevion Medical Systems |
| Distribution | US |
Product
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Reason
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
Identifiers
| code_info | S250-0001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1271-2014%22
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