Device recall
Z-1197-2012: Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips…
FDA device recall · Class II · Philips Medical Systems Nederlands
Key facts
| Recall number (Z-number) | Z-1197-2012 |
|---|---|
| Recall event | 61267 |
| Product | Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. |
| Product code | IZI |
| Recalling firm | Philips Medical Systems Nederlands |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2013 |
| 510(k) numbers | K023441 |
| FEI number | 3002807880 |
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