Date Initiated by Firm |
March 09, 2015 |
Create Date |
September 13, 2017 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number |
Z-3129-2017 |
Recall Event ID |
76905 |
510(K)Number |
K152257
|
Product Classification |
Duodenoscope and accessories, flexible/rigid - Product Code FDT
|
Product |
Fujifilm Endoscope Models
ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5
Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
|
Code Information |
will be entered. |
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 |
Fujifilm is conducting a corrective action due to an FDA inspection.
|
FDA Determined Cause 2 |
Other |
Action |
Fujifilm notified their customers on 3/9/2015. Customers are advised of the updated manuals. and asked to destroyed existing manuals. Questions, comments and concerns should be directed to 800.385.4666 between the areas of 8:00 am and 5:00 pm EST or via email at G5info@fujifilm.com. |
Quantity in Commerce |
260 manuals in total |
Distribution |
US Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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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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