FDA-Device2015-09-30Class II
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Fujifilm Medical Systems U.S.A., Inc.
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.
Sold states
Nationwide US and Canada
Affected count
60
Manufactured in
10 Highpoint Dr, N/A, Wayne, NJ, United States
Products
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2805-2015Don't want to check this manually?
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