Device recall
Z-0418-2016: Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT…
FDA device recall · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Recall number (Z-number) | Z-0418-2016 |
|---|---|
| Recall event | 72258 |
| Product | Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes. |
| Product code | FDT |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2018 |
| 510(k) numbers | K944759 |
| FEI number | 2431293 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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