Device product

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

Z-2805-2015

June 30, 2015

Class II

Product summary

Firm: Fujifilm Medical Systems U.S.A., Inc.
Event: Event 71706
Status: Terminated
Classification: Class II
Quantity: 60
Official record key: device-enforcement:Z-2805-2015

Official wording

Reason: 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.

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

Distribution pattern: Nationwide US and Canada

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.