Device recall
Z-2030-2025: GE Healthcare Versana Ultrasound Systems, sold under the following names and…
FDA device recall · Class II · GE Medical Systems China Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2030-2025 |
|---|---|
| Recall event | 96992 |
| Product | GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus… |
| Product code | IYN |
| Recalling firm | GE Medical Systems China Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K242005 |
| FEI number | 3003513129 |
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