Device product
Fujifilm Endoscope Model ED-530XT 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-3128-2017
Product summary
- Event
- Event 76905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 260 manuals in total
- Official record key
device-enforcement:Z-3128-2017
Official wording
Reason: Fujifilm is reporting a corrective action due to an FDA inspection.
Code information: For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Fujifilm is reporting a corrective action due to an FDA inspection.