MEVION S250 Radiation therapy system — Class II medical device recall Z-0767-2016
Terminated recall by Mevion Medical Systems, Inc., reported 2016-02-17, distributed nationwide. The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and trea
| Recall number | Z-0767-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mevion Medical Systems, Inc., Littleton, MA, United States |
| Recall initiated | 2015-11-18 |
| Classified | 2016-02-08 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2017-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Serial numbers | S250-0004 |
Product
MEVION S250 Radiation therapy system
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.