FDA-Device2013-11-06Class II
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
Fujinon Inc
Hazard
A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
Sold states
Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
Affected count
12 Units
Manufactured in
10 Highpoint Dr, N/A, Wayne, NJ, United States
Products
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0112-2014Don't want to check this manually?
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