Device recall
Z-1556-2025: Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-1556-2025 |
|---|---|
| Recall event | 96538 |
| Product | Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China… |
| Product code | IYN |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203137, K220848, K234106 |
| FEI number | 2126677 |
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