Device recall
Z-2284-2018: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus…
FDA device recall · Class II · Ion Beam Applications S.A.
Key facts
| Recall number (Z-number) | Z-2284-2018 |
|---|---|
| Recall event | 80217 |
| Product | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) |
| Product code | LHN |
| Recalling firm | Ion Beam Applications S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 25, 2020 |
| 510(k) numbers | K152224 |
| FEI number | 3000256071 |
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