Recall Z-2778-2015 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Fujifilm Medical Systems U.S.A., Inc.
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.
| Date | Sep 17, 2015 (initiated Jun 30, 2015) |
| Status | Terminated |
| Reason | The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures. |
| Root cause | Device Design |
| Action | FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers. |
| Quantity | 256 units |
| Distribution | Distributed in the US and Canada. |
| FDA record | Open on fda.gov |