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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 March 09, 2015
Create Date September 13, 2017
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-3129-2017
Recall Event ID 76905
510(K)Number K152257  
Product Classification Duodenoscope and accessories, flexible/rigid - Product Code FDT
Product Fujifilm Endoscope
Models

ED-250XL5
ED-250XT5
ED-450XT5
ED-450XL5

Product Usage:
This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Code Information will be entered.
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		 Fujifilm is conducting a corrective action due to an FDA inspection.
FDA Determined
Cause 2		 Other
Action Fujifilm notified their customers on 3/9/2015. Customers are advised of the updated manuals. and asked to destroyed existing manuals. Questions, comments and concerns should be directed to 800.385.4666 between the areas of 8:00 am and 5:00 pm EST or via email at G5info@fujifilm.com.
Quantity in Commerce 260 manuals in total
Distribution US Nationwide Distribution
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 = FDT and Original Applicant = FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
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