Device recall
Z-0705-2012: GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-0705-2012 |
|---|---|
| Recall event | 60773 |
| Product | GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. 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… |
| Product code | IYN |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2013 |
| 510(k) numbers | K110943 |
| FEI number | 2126677 |
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