Device recall event
Recall event 88521: Shanghai United Imaging Healthcare Co., Ltd.
FDA device recall · Class II · Open, Classified
Key facts
| Recall event number | 88521 |
|---|---|
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K182237, K193241 |
At a glance
- 1–9 Recalled products (Z-numbers)
- 1–9 Linked 510(k)s
- 10–99 Recall events for this firm
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall events
A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database