Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Reported: September 30, 2015 Initiated: June 30, 2015 #Z-2806-2015
Product Description
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
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.
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- multiple
- Distribution
- Nationwide US and Canada
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: multiple.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2015. Severity: Moderate. Recall number: Z-2806-2015.
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