Device recall
Z-0931-2018: Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System…
FDA device recall · Class II · Ion Beam Applications S.A.
Key facts
| Recall number (Z-number) | Z-0931-2018 |
|---|---|
| Recall event | 79228 |
| Product | Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to… |
| Product code | LHN |
| Recalling firm | Ion Beam Applications S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 2, 2019 |
| 510(k) numbers | K082416 |
| 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