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-410…
- Recall date
- August 31, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0418-2016
- FDA classification
- Class II
- Brand / firm
- Fujifilm Medical Systems U.S.A., Inc.
- Sold / distributed
- 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.
Why it was recalled
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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