Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2015 - (Recall #: Z-2805-2015)

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:

Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

Product Classification:

Class II

Date Initiated: June 30, 2015

Date Posted: September 30, 2015

Recall Number: Z-2805-2015

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: 60

Code Information:

Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E

Distribution Pattern:

Nationwide US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated