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.
|