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.
FDA Recall Z-3129-2017 · Posted None
Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeFDT
Date Initiated2015-03-09
Date Terminated2018-07-02
Product Quantity260 manuals in total
Reason for Recall
Fujifilm is conducting a corrective action due to an FDA inspection.
Firm 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 [email protected].
Root Cause
Other
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.