Device recall
Z-1137-2018: MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
FDA device recall · Class II · ESAOTE S.P.A.
Key facts
| Recall number (Z-number) | Z-1137-2018 |
|---|---|
| Recall event | 79547 |
| Product | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 |
| Product code | IYN |
| Recalling firm | ESAOTE S.P.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2019 |
| 510(k) numbers | K081386, K163082 |
| FEI number | 3012981490 |
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