Recall Z-2706-2017— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-2706-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-17

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2017-02-17, terminated 2018-10-03. It names one FDA 510(k) clearance: K063847. Product: Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs. Reason: Fujifilm is recalling multiple endoscopes after a retrospective review..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-17
Terminated: 2018-10-03
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K063847 — FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700Fujinon, Inc.·cleared 2007-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.