Device recall
Z-0947-2021: Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C…
FDA device recall · Class II · Philips Ultrasound Inc
Key facts
| Recall number (Z-number) | Z-0947-2021 |
|---|---|
| Recall event | 87156 |
| Product | Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses… |
| Product code | IYN |
| Recalling firm | Philips Ultrasound Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2023 |
| 510(k) numbers | K182857 |
| 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