Class 2 Device Recall Fujifilm Endoscope ED250XT5

• Date Initiated by Firm: December 23, 2015
• Create Date: May 31, 2016
• Recall Status: Terminated on January 18, 2018
• Recall Number: Z-1862-2016
• Recall Event ID: 73469
• 510(K)Number: K944759
• Product Classification: duodenoscope and accessories, flexible/rigid - Product Code FDT
• Product: Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
• Code Information: All distribution dates :3/2003-4/2016
• Recalling Firm/ Manufacturer: Fujifilm Medical Systems U.S.A., Inc.; 10 Highpoint Dr; Wayne NJ 07470-7431
• For Additional Information Contact: Mrs. Faye Dunn; 973-709-2202
• Manufacturer Reason for Recall: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
• FDA Determined Cause: Other
• Action: Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.
• Quantity in Commerce: 882 units
• Distribution: 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