Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2806-2015 — Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

U.S. FDA — Device Enforcement · United States · 2015-06-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2806-2015
Date of alert: 2015-06-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fujifilm Medical Systems U.S.A., Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2806-2015 — Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

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