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[Recalled] Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U — There was an increase in complaints indicating an occurrence of system error E1… | FDA 2024-09-04

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductOlympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Brand / manufacturerOlympus Corporation of the Americas
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0264-2025
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date04 September 2024
EAN / barcode04042761087698

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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).

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Olympus Corporation of the Americas

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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