FDA-Device2017-10-04Class II
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
Sold states
Nationwide
Affected count
362 units
Manufactured in
10 Highpoint Dr, N/A, Wayne, NJ, United States
Products
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3225-2017Don't want to check this manually?
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