Device recall
Z-2023-2021: The system is intended to produce cross-sectional images of the body by computer…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-2023-2021 |
|---|---|
| Recall event | 88208 |
| Product | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast… |
| Product code | JAK |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203169 |
| FEI number | 2126677 |
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