Device recall
Z-1263-2014: Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound…
FDA device recall · Class II · Philips Medical Systems North America Inc.
Key facts
| Recall number (Z-number) | Z-1263-2014 |
|---|---|
| Recall event | 67685 |
| Product | Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results… |
| Product code | IYN |
| Recalling firm | Philips Medical Systems North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2016 |
| 510(k) numbers | K132304 |
| FEI number | 1000524572 |
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