Device recall
Z-1895-2008: Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2…
FDA device recall · Class III · Philips Medical Systems North America Co. Phillips
Key facts
| Recall number (Z-number) | Z-1895-2008 |
|---|---|
| Recall event | 47539 |
| Product | Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excluding mammography. |
| Product code | KPR |
| Recalling firm | Philips Medical Systems North America Co. Phillips |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 7, 2011 |
| 510(k) numbers | K070528 |
| 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