Drug recall
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and…
FDA recall event 91664 · Class II · Brainlab AG
Key facts
| Event ID | 91664 |
|---|---|
| Recall numbers | Z-1259-2023 |
| Recalling firm | Brainlab AG |
| Product type | Devices |
| Products | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template |
| Initiation date | Feb 14, 2023 |
| Report date | Mar 22, 2023 |
| City | Munich |
| Country | Germany |
| FEI number | 3002619595 |
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: