Device recall
Z-2517-2023: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti…
FDA device recall · Class II · Philips Ultrasound, Inc.
Key facts
| Recall number (Z-number) | Z-2517-2023 |
|---|---|
| Recall event | 92761 |
| Product | 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000 |
| Product code | ITX |
| Recalling firm | Philips Ultrasound, Inc. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K042540, K043535, K081661, K120321, K132304, K222648 |
| 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