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.
FDA Recall Z-2338-2025 · Posted 2025-08-19
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2025-07-25
Product Quantity155 units
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'.
Firm Action
Olympus notified consignees via letter on about 07/25/2025. Consignees were instructed to examine inventory, identify any affected units, and continued use is permitted until the repair is performed as long as users follow the IFU. Olympus will contact consignees to arrange for the return of affected units to replace the affected part. Consignees were also instructed to notify customers, if the units were further distributed, and to acknowledge receipt of the letter through the Olympus web portal.
Root Cause
Component change control
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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