Device recall
Z-1415-2021: The EOSedge system may acquire two simultaneous orthogonal planar images for a…
FDA device recall · Class II · EOS Imaging
Key facts
| Recall number (Z-number) | Z-1415-2021 |
|---|---|
| Recall event | 87505 |
| Product | The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. The… |
| Product code | KPR |
| Recalling firm | EOS Imaging |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2023 |
| 510(k) numbers | K202394 |
| FEI number | 3006165260 |
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