Device recall
Z-2449-2010: BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20…
FDA device recall · Class II · Philips Medical Systems North America Co. Phillips
Key facts
| Recall number (Z-number) | Z-2449-2010 |
|---|---|
| Recall event | 56093 |
| Product | BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the… |
| Product code | IZI |
| Recalling firm | Philips Medical Systems North America Co. Phillips |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2011 |
| 510(k) numbers | K031333, K033737 |
| 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