FDA-Device2017-09-20Class II
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.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
Fujifilm is conducting a corrective action due to an FDA inspection.
Sold states
US Nationwide Distribution
Affected count
260 manuals in total
Manufactured in
10 Highpoint Dr, N/A, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3129-2017Don't want to check this manually?
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