Device recall
Z-0224-2026: Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and…
FDA device recall · Class II · UIH Technologies LLC
Key facts
| Recall number (Z-number) | Z-0224-2026 |
|---|---|
| Recall event | 97668 |
| Product | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only |
| Product code | JAK |
| Recalling firm | UIH Technologies LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172143 |
| FEI number | 3014809646 |
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