Device 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.
Z-3129-2017
Product summary
- Event
- Event 76905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 260 manuals in total
- Official record key
device-enforcement:Z-3129-2017
Official wording
Reason: Fujifilm is conducting a corrective action due to an FDA inspection.
Code information: will be entered.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Fujifilm is conducting a corrective action due to an FDA inspection.