Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

Recall date
September 4, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0264-2025
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US Nationwide.

Why it was recalled

There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

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

What was recalled

Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

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