FDAJune 30, 2015device
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
fujifilm medical systems ufujifilmfujifilm medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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