Device recall
Z-1708-2020: Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with…
FDA device recall · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1708-2020 |
|---|---|
| Recall event | 85340 |
| Product | Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization… |
| Product code | KPS |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2022 |
| 510(k) numbers | K182237 |
| 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