Device recall
Z-1380-2016: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C…
FDA device recall · Class II · Philips Ultrasound, Inc.
Key facts
| Recall number (Z-number) | Z-1380-2016 |
|---|---|
| Recall event | 73665 |
| Product | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric… |
| Product code | IYN |
| Recalling firm | Philips Ultrasound, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2017 |
| 510(k) numbers | K132304 |
| FEI number | 3019216 |
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