Device recall
Z-2199-2019: Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models…
FDA device recall · Class II · Philips Ultrasound Inc
Key facts
| Recall number (Z-number) | Z-2199-2019 |
|---|---|
| Recall event | 83003 |
| Product | Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic… |
| Product code | IYN |
| Recalling firm | Philips Ultrasound Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2022 |
| 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