}

Fujifilm updates manual and parts for duodenoscopes

07/25/2017

Fujifilm issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-530XT duodenoscopes. This action includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The U.S. Food and Drug Administration (FDA) cleared the updated design and labeling for the ED-530XT on July 21, 2017. Read the FDA safety alert.

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