[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U |
|---|---|
| Brand / manufacturer | Olympus Corporation of the Americas |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0264-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 September 2024 |
| EAN / barcode | 04042761087698 |
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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