Device recall
Z-0282-2016: BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0282-2016 |
|---|---|
| Recall event | 71248 |
| Product | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative 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 28, 2017 |
| 510(k) numbers | K070106 |
| 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