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Fujinon Inc recalls Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of th
Recalled November 6, 2013 · FDA recall Z-0112-2014 · Fujinon
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. · FDA Class II
Units
12 Units
Sold at
Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
Description
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.
Product
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.
Manufacturer(s)
Fujinon Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →