Device recall
Z-2470-2018: Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with…
FDA device recall · Class II · Ion Beam Applications S.A.
Key facts
| Recall number (Z-number) | Z-2470-2018 |
|---|---|
| Recall event | 80384 |
| Product | Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small… |
| Product code | LHN |
| Recalling firm | Ion Beam Applications S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2020 |
| 510(k) numbers | K060695 |
| 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