Device recall
Z-2988-2018: GE Vivid E95 ultrasound system Product The device is intended for use by a…
FDA device recall · Class II · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Key facts
| Recall number (Z-number) | Z-2988-2018 |
|---|---|
| Recall event | 80928 |
| Product | GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral… |
| 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