Device recall
Z-0756-2023: Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0756-2023 |
|---|---|
| Recall event | 91139 |
| Product | Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and… |
| Product code | ITX |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K033139, K061525, K082374, K092140 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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