FDA-Device2015-09-23Class II
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
Sold states
Distributed in the US and Canada.
Affected count
256 units
Manufactured in
10 Highpoint Dr, Wayne, NJ, United States
Products
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2778-2015Don't want to check this manually?
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