Device recall
Z-0827-2022: Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N…
FDA device recall · Class II · Mevion Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0827-2022 |
|---|---|
| Recall event | 89758 |
| Product | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) |
| Product code | LHN |
| Recalling firm | Mevion Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K120676, K172848 |
| FEI number | 3007087027 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database