Recall Z-0418-2016 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Fujifilm Medical Systems U.S.A., Inc.
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.
| Date | Aug 31, 2015 |
| Status | Terminated |
| Reason | A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing. |
| Root cause | Device Design |
| Action | FujiFilm mailed a Medical Device Recall Letter and Tracking/Verification Form dated August 31, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to check their inventory for affected product, if found, affected product should be removed from circulation and returned to Fugifilm. Customers were also asked to complete and return the enclosed tracking/verification form to Fujifilm Medical Systems USA, Inc., Endoscopy Division (FMSU-ESD), 10 High Point Drive, Wayne, NJ 07470 or via fax to 973-633-8 |
| Quantity | 79 units (US) and 985 units (Internationally) |
| Distribution | US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan. |
| 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 |