Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical
Pending LLM rewrite. Source: FDA_DEVICE Z-2338-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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'.
The recalled product
- 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
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 101697
- 101698
- 101699
- 101700
- 101701
- 101702
- 101703
- 101704
- 101705
- 101706
- 101707
- 101708
- 101709
- 101710
- 101919
- 101920
- 101921
- 101922
- 101923
- 101924
Distribution
Distributed nationwide across the United States.
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