Electrosurgical generators recalled over system error causing reboots during use
The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a generator that reboots during a procedure could interrupt surgery, and the notice reports no injuries.
Plain-English summary
The ESG-410 Surgical Energy Platform electrosurgical generator, model number WA91327U, UDI-DI 04042761087698, is being recalled. The device is an electrosurgical generator used for monopolar and bipolar cutting and coagulation. Affected units are identified by the serial numbers listed in the recall notice. The recall covers 155 units distributed nationwide in the United States.
The recall was issued because of the potential for the generator to display the error message "E0662 System Error", followed by either an automatic single reboot of the device or a continuous reboot loop. The FDA classified the action as Class II.
Hospitals and surgical centres should check their serial numbers against the recall notice and follow the manufacturer's instructions for affected generators.
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
- Affected units
- 155
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.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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