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U.S. Department of Health and Human Services

Class 2 Device Recall FUJINON ED530XT

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  Class 2 Device Recall FUJINON ED530XT see related information
Date Initiated by Firm July 21, 2017
Create Date September 27, 2017
Recall Status1 Terminated 3 on July 12, 2018
Recall Number Z-3225-2017
Recall Event ID 78065
510(K)Number K152257  
Product Classification Duodenoscope and accessories, flexible/rigid - Product Code FDT
Product FUJINON ED-530XT.

This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Code Information All lots/serial numbers
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
10 Highpoint Dr
Wayne NJ 07470-7431
For Additional Information Contact Larry Picciano
973-686-2479
Manufacturer Reason
for Recall		 An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
FDA Determined
Cause 2		 Device Design
Action On July 21, 2017, Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division distributed Urgent Medical Device Correction and Removal notices & Field Action Verification Forms to their U.S. Consignees by USPS certified mail. Fujifilm Medical Systems will contact all customers that have the duodenoscope by October 2017, with details for returning the device for replacement parts. This field action allows continued use of the current device until you are contacted by a sales representative for replacement parts as early as October 2017. While the remediation of the scopes will take approximately two weeks to complete, Fujifilm Medical Systems U.S.A. Inc. Endoscopy Division will provide interim duodenoscopes on loan for continuity of care. Once received, the recalling firm will replace the forceps elevator mechanism with O-ring and the distal end cap. An updated manual has been generated to include new information/guidance. Customers are encouraged to complete and return the Field Action Verification Form via email to fnonmedicalqa@fujifilm.com or via fax to (973) 872-4723. Customers with questions can call Larry Picciano, Sr. Director Quality and Regulatory Affairs at (973) 686-2479.
Quantity in Commerce 362 units
Distribution Nationwide
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 = FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
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