Device recall
Z-1877-2013: Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a…
FDA device recall · Class II · Carestream Health Inc.
Key facts
| Recall number (Z-number) | Z-1877-2013 |
|---|---|
| Recall event | 65369 |
| Product | Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. |
| Product code | KPR |
| Recalling firm | Carestream Health Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2014 |
| 510(k) numbers | K091889 |
| FEI number | 1315356 |
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