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Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to obs
Recalled September 30, 2015 · FDA recall Z-2806-2015 · Fujifilm Medical Systems U.S.A
Hazard
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. · FDA Class II
Units
multiple
Sold at
Nationwide US and Canada
Description
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.
Product
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →