Device recall
Z-2593-2021: uMI 550 System - Product Usage: intended to be operated by qualified healthcare…
FDA device recall · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2593-2021 |
|---|---|
| Recall event | 88521 |
| Product | uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and… |
| Product code | KPS |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K182237, K193241 |
| FEI number | 3011015597 |
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