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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm Endoscope; ED530XT

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  Class 2 Device Recall Fujifilm Endoscope; ED530XT see related information
Date Initiated by Firm December 23, 2015
Create Date May 31, 2016
Recall Status1 Terminated 3 on January 18, 2018
Recall Number Z-1860-2016
Recall Event ID 73469
510(K)Number K042076  
Product Classification duodenoscope and accessories, flexible/rigid - Product Code FDT
Product Endoscope; ED-530XT Operation Manual
'Operation and Preparation' and '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 2
Other
Action Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.
Quantity in Commerce 1473 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 and Original Applicant = FUJINON, INC.
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