Device recall
Z-0747-2022: ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for…
FDA device recall · Class II · Ion Beam Applications S.A.
Key facts
| Recall number (Z-number) | Z-0747-2022 |
|---|---|
| Recall event | 89731 |
| Product | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235 |
| Product code | LHN |
| Recalling firm | Ion Beam Applications S.A. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K163500 |
| 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