FDA recall Z-0264-2025

Olympus Corporation of the Americas · Class II · device

Product

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

Reason for recall

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).

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2024-09-04
Report date: 2024-11-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2025