FDA: All ED-530XT duodenoscopes by Fujifilm recalled

Editor's Note

The Food and Drug Administration (FDA) on July 21 announced the recall by Fujifilm of its ED-530XT duodenoscopes.

The recall includes replacement of the ED-530XT forceps elevator mechanism including the o-ring seal, replacement of the distal end cap, and a new operations manual.

The FDA cleared the updated design and labeling for the ED-530XT on July 21.

Posted 07/21/2017] AUDIENCE: Gastroenterology, Risk Manager ISSUE: On July 21, 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.