Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagn…

Recall date
April 19, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2629-2017
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
Nationwide Distribution

Why it was recalled

Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

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

What was recalled

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

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