FDA Device recall Z-0588-2015
MEVION S250, used for proton radiation therapy
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of MEVION S250, used for proton radiation therapy by Mevion Medical Systems, citing software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. T….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0588-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-10 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mevion Medical Systems |
| Distribution | MO |
Product
MEVION S250, used for proton radiation therapy.
Reason
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
Identifiers
| code_info | Serial Number: 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-0588-2015%22
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