Device recall
Z-1599-2016: Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
FDA device recall · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Recall number (Z-number) | Z-1599-2016 |
|---|---|
| Recall event | 73668 |
| Product | Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU |
| Product code | IXW |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2018 |
| 510(k) numbers | K944046 |
| FEI number | 1000513161 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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