Fujifilm Medical Systems U.S.A., Inc. recalls FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically…

Recall date

July 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3225-2017

FDA classification

Class II

Brand / firm

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

Sold / distributed

Nationwide

Why it was recalled

An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.

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

What was recalled

FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.