FDA-Device2024-11-06Class II
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Olympus Corporation of the Americas
Hazard
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).
Sold states
US Nationwide.
Affected count
279 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2025Don't want to check this manually?
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