Device recall
Z-2778-2015: Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT…
FDA device recall · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Recall number (Z-number) | Z-2778-2015 |
|---|---|
| Recall event | 71695 |
| Product | Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals. |
| Product code | FDT |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2017 |
| 510(k) numbers | K042076 |
| 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