The Recall Desk

FDA (Devices) recall action 71706

Fujifilm Medical Systems U.S.A., Inc. recalled 2 products on 2015-09-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-09-30
Critical
0
Units
60

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Devices)··2015-09-30

    Fujifilm EPX 2500 Processor Manual and Brochure Recall

    Fujifilm is recalling EPX 2500 Processor manuals and brochures that incorrectly identify the ED-530XT endoscope's image quality.

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