Device recall
Z-0797-2014: DRX-Evolution with CSH WS These products are permanently installed diagnostic…
FDA device recall · Class II · Carestream Health, Inc.
Key facts
| Recall number (Z-number) | Z-0797-2014 |
|---|---|
| Recall event | 67047 |
| Product | DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or… |
| Product code | IZL |
| Recalling firm | Carestream Health, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2016 |
| 510(k) numbers | K091889 |
| FEI number | 1317307 |
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