Device recall
Z-0485-2021: MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage…
FDA device recall · Class II · Mevion Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0485-2021 |
|---|---|
| Recall event | 86693 |
| Product | MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation |
| Product code | LHN |
| Recalling firm | Mevion Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2021 |
| 510(k) numbers | 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