Device recall
Z-0588-2015: MEVION S250, used for proton radiation therapy.
FDA device recall · Class II · Mevion Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0588-2015 |
|---|---|
| Recall event | 69778 |
| Product | MEVION S250, used for proton radiation therapy. |
| Product code | LHN |
| Recalling firm | Mevion Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2015 |
| 510(k) numbers | K120676 |
| 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