Device recall
Z-0056-2021: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0056-2021 |
|---|---|
| Recall event | 86438 |
| Product | Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: 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 II |
| Status | Terminated |
| Termination date | Feb 17, 2021 |
| 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