Class 2 Device Recall Fujifilm

• Date Initiated by Firm: June 30, 2015
• Date Posted: September 22, 2015
• Recall Status: Terminated on May 25, 2017
• Recall Number: Z-2806-2015
• Recall Event ID: 71706
• 510(K)Number: K944759
• Product Classification: Endoscopic video imaging system/component, gastroenterology-urology - Product Code FET
• Product: Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
• Code Information: 2500.0312.00 and 2500.0312.01
• Recalling Firm/ Manufacturer: Fujifilm Medical Systems U.S.A., Inc.; 10 Highpoint Dr; Wayne NJ 07470-7431
• For Additional Information Contact: Ms. Sarah Contreras; 973-709-2202
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Fujifilm Medical Systems USA, Inc. initiated this recall by sending a Voluntary Field Correction Letter and Tracking/Verification Form dated June 30, 2013 to their affected customers.
• Quantity in Commerce: multiple
• Distribution: Nationwide US and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FET