Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2015 - (Recall #: Z-2806-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 30, 2015

Date Posted: September 30, 2015

Recall Number: Z-2806-2015

Event ID: 71706

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.

Status: Terminated

Product Quantity: multiple

Code Information:

2500.0312.00 and 2500.0312.01

Distribution Pattern:

Nationwide US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated