Device recall
Z-1066-2016: Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper…
FDA device recall · Class II · Philips Electronics North America Corporation
Key facts
| Recall number (Z-number) | Z-1066-2016 |
|---|---|
| Recall event | 72325 |
| Product | Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker… |
| Product code | OWB |
| Recalling firm | Philips Electronics North America Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2020 |
| 510(k) numbers | K141979 |
| FEI number | 1218950 |
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