Device recall
Z-3158-2024: The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI…
FDA device recall · Class II · FUJIFILM Healthcare Americas Corporation
Key facts
| Recall number (Z-number) | Z-3158-2024 |
|---|---|
| Recall event | 95320 |
| Product | The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled. |
| Product code | IZL |
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170858 |
| FEI number | 1000513161 |
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