Device recall
Z-0446-2021: Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036…
FDA device recall · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0446-2021 |
|---|---|
| Recall event | 86269 |
| Product | Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck… |
| Product code | JAK |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K181414 |
| 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