Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Reported: September 30, 2015 Initiated: June 30, 2015 #Z-2805-2015
Product Description
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
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
- 60
- Distribution
- Nationwide US and Canada
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 60.
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-2805-2015.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11