FDA recall Z-2706-2017

Fujifilm Medical Systems U.S.A., Inc. · Class II · device

Product

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

Reason for recall

Fujifilm is recalling multiple endoscopes after a retrospective review.

Distribution

US Distribution to : AL, HI and MO

Key facts

Status
Terminated
Initiation date
2017-02-17
Report date
2017-07-19
Termination date
2018-10-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

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