Device recall
Z-0179-2014: DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by…
FDA device recall · Class II · Carestream Health Inc.
Key facts
| Recall number (Z-number) | Z-0179-2014 |
|---|---|
| Recall event | 66067 |
| Product | DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients |
| Product code | IZL |
| Recalling firm | Carestream Health Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 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