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Recall Observatory FDA recall evidence

Device 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.

Z-0418-2016

August 31, 2015

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 72258
Status
Terminated
Classification
Class II
Quantity
79 units (US) and 985 units (Internationally)
Official record key
device-enforcement:Z-0418-2016

Official wording

Reason: A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.

Code information: Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107 Model Number: ED-200XT: Serial Number: 8681034 Model Number: ED-250XT: Serial Number: HD077A008 Model Number: ED-310XU: Serial Number: 8591013 Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026 Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022 Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100 Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020 Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.