FDA-Device2017-07-19Class II

Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

Fujifilm Medical Systems U.S.A., Inc.
Hazard

Fujifilm is recalling multiple endoscopes after a retrospective review.

Sold states
US Distribution to : AL, HI and MO
Affected count
4 units
Manufactured in
10 Highpoint Dr, Wayne, NJ, United States
Products
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2706-2017

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