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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 17, 2015
Recall Status1 Terminated 3 on May 25, 2017
Recall Number Z-2778-2015
Recall Event ID 71695
510(K)Number K042076  K944620  
Product Classification duodenoscope and accessories, flexible/rigid - Product Code FDT
Product Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
Code Information ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681
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 suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
FDA Determined
Cause 2		 Device Design
Action FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers.
Quantity in Commerce 256 units
Distribution Distributed in the 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 = FDT and Original Applicant = FUJINON, INC.
510(K)s with Product Code = FDT and Original Applicant = MARKS & MURASE
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