CLASS II Device recall · Reported 30 Sep 2015 · FDA Enforcement Report

Fujifilm Processor EPX 2500 High Definition Endoscopy recalled

Fujifilm Medical Systems U.S.A is recalling Fujifilm Processor EPX 2500 High Definition Endoscopy, distributed nationwide in the US. The recall was initiated on 30 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes2500.0312.00 and 2500.0312.01

Quantity recalledmultiple

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2806-2015
FDA event ID: 71706
Recalling firm: Fujifilm Medical Systems U.S.A, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 30 Jun 2015
FDA classified: 22 Sep 2015
Reported: 30 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

30 Jun 2015	Recall initiated by company
22 Sep 2015	Classified by FDA	+84 days
30 Sep 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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 as listed by the FDA

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

Where it was distributed

Nationwide US and Canada

Nationwide

Questions about this recall

Is Fujifilm Processor EPX 2500 High Definition Endoscopy recalled?

Yes. Fujifilm Medical Systems U.S.A recalled Fujifilm Processor EPX 2500 High Definition Endoscopy on 30 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2806-2015.

Why was it recalled?

Which lots are affected?

2500.0312.00 and 2500.0312.01

Where was it sold?

Nationwide US and Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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