FDA Device recall Z-1529-2016
MEVION S250 for Proton Radiation Therapy
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of MEVION S250 for Proton Radiation Therapy by Mevion Medical Systems, citing possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and caus….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1529-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-15 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mevion Medical Systems |
| Distribution | US |
Product
MEVION S250 for Proton Radiation Therapy
Reason
Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.
Identifiers
| code_info | S250-0002 |
|---|
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-1529-2016%22
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