Device recall
Z-1839-2019: LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1839-2019 |
|---|---|
| Recall event | 82938 |
| Product | LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e… |
| Product code | IYN |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161588 |
| 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