Recall Z-3129-2017 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Fujifilm Medical Systems U.S.A., Inc.
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.
| Date | Mar 9, 2015 |
| Status | Terminated |
| Reason | Fujifilm is conducting a corrective action due to an FDA inspection. |
| Root cause | 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 | 260 manuals in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152257 | Fujifilm Duodenoscope Model ED-530XT Fujifilm Medical Systems U.S.A, Inc., Jul 21, 2017 |