Device recall
Z-1898-2024: FDR Visionary Suite - Intended to generate digital or conventional radiographic…
FDA device recall · Class II · FUJIFILM Healthcare Americas Corporation
Key facts
| Recall number (Z-number) | Z-1898-2024 |
|---|---|
| Recall event | 94443 |
| Product | FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33 |
| Product code | KPR |
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152294 |
| 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