Device recall
Z-0090-2014: DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY…
FDA device recall · Class II · Carestream Health, Inc.
Key facts
| Recall number (Z-number) | Z-0090-2014 |
|---|---|
| Recall event | 65805 |
| Product | DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment… |
| Product code | IZL |
| Recalling firm | Carestream Health, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 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