Device recall
Z-0289-2024: The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system…
FDA device recall · Class II · Carestream Health, Inc.
Key facts
| Recall number (Z-number) | Z-0289-2024 |
|---|---|
| Recall event | 93253 |
| Product | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary… |
| Product code | IZL |
| Recalling firm | Carestream Health, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191025 |
| FEI number | 1317307 |
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