Device recall
Z-2476-2021: The Azurion series (within the limits of the used Operation Room table) are…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2476-2021 |
|---|---|
| Recall event | 88546 |
| Product | The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures… |
| Product code | OWB |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2024 |
| 510(k) numbers | K162148 |
| 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