Device recall
Z-2449-2015: CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently…
FDA device recall · Class II · Carestream Health Inc
Key facts
| Recall number (Z-number) | Z-2449-2015 |
|---|---|
| Recall event | 71848 |
| Product | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. |
| Product code | KPR |
| Recalling firm | Carestream Health Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2016 |
| 510(k) numbers | K141837 |
| 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