FDA Device recall Z-0767-2016
MEVION S250 Radiation therapy system
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of MEVION S250 Radiation therapy system by Mevion Medical Systems, citing the treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slip….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0767-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-18 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mevion Medical Systems |
| Distribution | US |
Product
MEVION S250 Radiation therapy system
Reason
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
Identifiers
| code_info | Manufacturing Lot or Serial Number: S250-0004 |
|---|
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-0767-2016%22
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