Drug recall
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The…
FDA recall event 71924 · Class I · Brainlab AG
Key facts
| Event ID | 71924 |
|---|---|
| Recall numbers | Z-0598-2016 |
| Recalling firm | Brainlab AG |
| Product type | Devices |
| Products | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an… |
| Initiation date | Apr 22, 2013 |
| Report date | Jan 27, 2016 |
| Termination date | Apr 17, 2018 |
| 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: