Drug recall
Proteus 235-Proton Therapy System
FDA recall event 88196 · Class II · Ion Beam Applications S.A.
Key facts
| Event ID | 88196 |
|---|---|
| Recall numbers | Z-2155-2021 |
| Recalling firm | Ion Beam Applications S.A. |
| Product type | Devices |
| Products | Proteus 235-Proton Therapy System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as… |
| Initiation date | May 26, 2021 |
| Report date | Aug 4, 2021 |
| 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: