Device recall
Z-2986-2018: GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is…
FDA device recall · Class II · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Key facts
| Recall number (Z-number) | Z-2986-2018 |
|---|---|
| Recall event | 80928 |
| Product | GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal… |
| Product code | IYN |
| Recalling firm | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2021 |
| 510(k) numbers | K150087, K170823, K173341 |
| FEI number | 3005860720 |
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