Recall Z-2806-2015— Fujifilm Medical Systems U.S.A., Inc.
Class II · Terminated
Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2015-06-30, terminated 2017-05-25. It names one FDA 510(k) clearance: K944759. Product: Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.. 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..
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-30
- Terminated
- 2017-05-25
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.