Drug recall
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116…
FDA recall event 67678 · Class II · Ion Beam Applications S.A.
Key facts
| Event ID | 67678 |
|---|---|
| Recall numbers | Z-1492-2014 |
| Recalling firm | Ion Beam Applications S.A. |
| Product type | Devices |
| Products | Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). |
| Initiation date | Dec 4, 2013 |
| Report date | Apr 30, 2014 |
| Termination date | Jun 12, 2014 |
| 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: