Recall Z-2805-2015 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Fujifilm Medical Systems U.S.A., Inc.
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
| Date | Sep 22, 2015 (initiated Jun 30, 2015) |
| Status | Terminated |
| Reason | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed. |
| Root cause | Device Design |
| Action | Fujifilm Medical Systems USA, Inc. initiated this recall by sending a Voluntary Field Correction Letter and Tracking/Verification Form dated June 30, 2013 to their affected customers. |
| Quantity | 60 |
| Distribution | Nationwide US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944759 | 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM Fujinon, Inc., Apr 11, 1995 |