FDA recall Z-2415-2024

Olympus Corporation of the Americas · Class II · device

Product

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

Reason for recall

Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-06-21
Report date
2024-07-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2415-2024