Device recall
Z-2983-2018: GE LOGIQ E9 ultrasound system Product Usage: 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-2983-2018 |
|---|---|
| Recall event | 80928 |
| Product | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular… |
| Product code | IYO |
| Recalling firm | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2021 |
| 510(k) numbers | K082185, K092271, K110943, K123564, K142160 |
| FEI number | 3005860720 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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