Device recall
Z-0800-2015: DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog…
FDA device recall · Class II · Carestream Health Inc
Key facts
| Recall number (Z-number) | Z-0800-2015 |
|---|---|
| Recall event | 69826 |
| Product | DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor… |
| Product code | IZL |
| Recalling firm | Carestream Health Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 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