Device recall
Z-2084-2015: NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided…
FDA device recall · Class II · Northern Digital Inc.
Key facts
| Recall number (Z-number) | Z-2084-2015 |
|---|---|
| Recall event | 69804 |
| Product | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the… |
| Product code | HAW |
| Recalling firm | Northern Digital Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 3, 2016 |
| 510(k) numbers | K100038 |
| FEI number | 3002743211 |
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