FDA recall Z-2339-2025

Olympus Corporation of the Americas · Class II · device

Product

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

Reason for recall

Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-07-25
Report date
2025-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2025