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U.S. Department of Health and Human Services

Class 2 Device Recall Dudenoscope

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  Class 2 Device Recall Dudenoscope see related information
Date Initiated by Firm August 31, 2015
Create Date December 15, 2015
Recall Status1 Terminated 3 on March 21, 2018
Recall Number Z-0418-2016
Recall Event ID 72258
510(K)Number K944759  
Product Classification duodenoscope and accessories, flexible/rigid - Product Code FDT
Product Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
Code Information Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107  Model Number: ED-200XT: Serial Number: 8681034  Model Number: ED-250XT: Serial Number: HD077A008  Model Number: ED-310XU: Serial Number: 8591013  Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026  Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022  Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100  Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020  Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051 
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
10 Highpoint Dr
Wayne NJ 07470-7431
For Additional Information Contact Ms. Sarah Contreras
973-686-2482
Manufacturer Reason
for Recall		 A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
FDA Determined
Cause 2		 Device Design
Action FujiFilm mailed a Medical Device Recall Letter and Tracking/Verification Form dated August 31, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to check their inventory for affected product, if found, affected product should be removed from circulation and returned to Fugifilm. Customers were also asked to complete and return the enclosed tracking/verification form to Fujifilm Medical Systems USA, Inc., Endoscopy Division (FMSU-ESD), 10 High Point Drive, Wayne, NJ 07470 or via fax to 973-633-8818. Customers with questions were instructed to contact their Fujifilm sales representative. For questions regarding this recall call 973-686-2482
Quantity in Commerce 79 units (US) and 985 units (Internationally)
Distribution US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.
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.
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