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Olympus Corporation of the Americas recalls Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SE

Recalled August 27, 2025 · FDA recall Z-2338-2025 · Olympus Corporation of the Americas

Hazard
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'. · FDA Class II
Units
155 units
Sold at
US Nationwide distribution.

Description

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'.

Product
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. 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.
Manufacturer(s)
Olympus Corporation of the Americas

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov