Medical Device Safety and Recalls: FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication

The Food and Drug Administration issued a Safety Communication to inform health care facilities that FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) is removing legacy 250/450 duodenoscope models from clinical use.  Fuji will replace these models with the current ED-530XT model at no cost to customers.  The validated reprocessing instructions for the current ED-530XT duodenoscope model outlined in December 2015 remain the same. Health care facilities should continue to use these validated instructions when reprocessing Fuji ED-530XT duodenoscopes.