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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm

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  Class 2 Device Recall Fujifilm see related information
Date Initiated by Firm June 30, 2015
Date Posted September 22, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = FUJINON, INC.
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