Class 2 Device Recall FujiFilm

• Date Initiated by Firm: June 30, 2015
• Date Posted: September 17, 2015
• Recall Status: Terminated 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: 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; 510(K)s with Product Code = FDT