Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to The EPX-2500 Operation Manual and sales brochure incorrectly...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Medical Systems U.S.A., Inc. directly.
Affected Products
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Quantity: 60
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report