Drug recall
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
FDA recall event 67926 · Class II · Brainlab AG
Key facts
| Event ID | 67926 |
|---|---|
| Recall numbers | Z-1707-2014 |
| Recalling firm | Brainlab AG |
| Product type | Devices |
| Products | ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially… |
| Initiation date | Apr 15, 2014 |
| Report date | Jun 11, 2014 |
| Termination date | Apr 24, 2017 |
| City | Feldkirchen |
| 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: