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Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-41
Recalled December 23, 2015 · FDA recall Z-0418-2016 · Fujifilm Medical Systems U.S.A
Hazard
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing. · FDA Class II
Units
79 units (US) and 985 units (Internationally)
Sold at
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.
Description
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Product
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.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →