Device recall
Z-0124-2011: Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and…
FDA device recall · Class II · Philips Medical Systems North America Co. Phillips
Key facts
| Recall number (Z-number) | Z-0124-2011 |
|---|---|
| Recall event | 49488 |
| Product | Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified… |
| Product code | IZI |
| Recalling firm | Philips Medical Systems North America Co. Phillips |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2010 |
| 510(k) numbers | K041949 |
| FEI number | 1000524572 |
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