Drug recall
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names…
FDA recall event 79228 · Class II · Ion Beam Applications S.A.
Key facts
| Event ID | 79228 |
|---|---|
| Recall numbers | Z-0931-2018 |
| Recalling firm | Ion Beam Applications S.A. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. |
| Initiation date | Oct 19, 2017 |
| Report date | Mar 14, 2018 |
| Termination date | Apr 2, 2019 |
| City | Louvain La Neuve |
| Country | Belgium |
| FEI number | 3000256071 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: