Medical device recalls Moderate risk

Fujifilm Medical Systems U.S.A., Inc. recalls Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of sub…

Recall date
February 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2706-2017
FDA classification
Class II
Brand / firm
Fujifilm Medical Systems U.S.A., Inc.
Sold / distributed
US Distribution to : AL, HI and MO

Why it was recalled

Fujifilm is recalling multiple endoscopes after a retrospective review.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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