Device recall
Z-0553-2024: The System is designed as a modular system with components that include an…
FDA device recall · Class II · GE Hangwei Medical Systems, Co. LTD
Key facts
| Recall number (Z-number) | Z-0553-2024 |
|---|---|
| Recall event | 93479 |
| Product | The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including… |
| Product code | KPR |
| Recalling firm | GE Hangwei Medical Systems, Co. LTD |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191699 |
| FEI number | 3002175190 |
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