Device recall
Z-0132-2014: DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty…
FDA device recall · Class II · Carestream Health Inc.
Key facts
| Recall number (Z-number) | Z-0132-2014 |
|---|---|
| Recall event | 65586 |
| Product | DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas |
| Product code | IZL |
| Recalling firm | Carestream Health Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2016 |
| 510(k) numbers | K120062 |
| 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