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Fujifilm Recalls ED-530XT Duodenoscope In 'Abundance Of Caution'

Executive Summary

Fujifilm Medical Systems issued an urgent medical device correction and removal for its ED-530XT duodenoscope on July 21. The company said it needed to update and replace the scope's forceps elevator mechanism and O-ring seal, distal end cap, and operations manuals in an "abundance of caution" to reduce risk to public health from inadequate reprocessing. FDA said it was working with Fujifilm on the correction.

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