ESG-410 Electrosurgical Generator Recalled for System Error and Reboot Malfunction
The Olympus ESG-410 Electrosurgical Generator may display an E0662 system error and reboot unexpectedly. The FDA Class II recall affects 155 units distributed nationwide, with specific serial numbers listed in the recall notice.
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: This is an FDA Class II medical device recall involving a potential system malfunction. No illnesses or injuries have been reported. The hazard is operational—system error and reboot failure could interrupt surgical procedures—fitting the 'high-risk products where injury has not yet been reported' category.
Plain-English summary
Olympus Corporation of the Americas is recalling the ESG-410 Electrosurgical Generator Surgical Energy Platform (Model WA91327U). The device may display an 'E0662 System Error' message and either reboot automatically one time or enter a continuous reboot loop.
The recall affects 155 units distributed nationwide in the United States. Affected devices have the lot code ESG-410 (SEP) WA91327U and specific serial numbers identified in the FDA recall notice.
This is a Class II recall issued by the FDA. The malfunction could affect the device's availability during surgical procedures. Hospitals and surgical facilities should verify their equipment against the list of recalled serial numbers and follow instructions from Olympus Corporation of the Americas regarding next steps.
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
- Hazard
- system-error
- device-malfunction
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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