FDA-Device2017-09-20Class II
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.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
Fujifilm is reporting 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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3128-2017Don't want to check this manually?
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