Device recall
Z-0598-2016: Brainlab Cranial Navigation System: An Image Guided Surgery System /…
FDA device recall · Class I · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0598-2016 |
|---|---|
| Recall event | 71924 |
| Product | 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 system to enable minimally invasive surgery. |
| Product code | HAW |
| Recalling firm | Brainlab AG |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 17, 2018 |
| 510(k) numbers | K092467 |
| FEI number | 3002619595 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database