Fujifilm Medical Systems U.S.A., Inc. recalls Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

Recall date

June 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2805-2015

FDA classification

Class II

Brand / firm

Fujifilm Medical Systems U.S.A., Inc.

Sold / distributed

Nationwide US and Canada

Why it was recalled

The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.