Device recall
Z-2475-2021: The Allura Xper series is intended for use on human patients to perform…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2475-2021 |
|---|---|
| Recall event | 88546 |
| Product | The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as… |
| Product code | OWB |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2024 |
| 510(k) numbers | K141979 |
| FEI number | 3016618143 |
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