FDA-Device2015-12-23Class II
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.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Sold states
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.
Affected count
79 units (US) and 985 units (Internationally)
Manufactured in
10 Highpoint Dr, N/A, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0418-2016Don't want to check this manually?
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