Device recall
Z-1138-2017: Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397…
FDA device recall · Class II · Carestream Health Inc
Key facts
| Recall number (Z-number) | Z-1138-2017 |
|---|---|
| Recall event | 76134 |
| Product | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 |
| Product code | IZL |
| Recalling firm | Carestream Health Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 13, 2018 |
| 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