Device recall
Z-0416-2022: Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-0416-2022 |
|---|---|
| Recall event | 89203 |
| Product | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026… |
| Product code | OWB |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2024 |
| 510(k) numbers | K130842, K161563 |
| 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