PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 19, 2017 Initiated: February 17, 2017 #Z-2706-2017

Product Description

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.

Details

Units Affected
4 units
Distribution
US Distribution to : AL, HI and MO
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 4 units.
Why was this product recalled?
Fujifilm is recalling multiple endoscopes after a retrospective review.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2706-2017.