FDA-Device2025-10-22Class II
XERF EFFECTOR 60. Electrosurgical unit.
Lutronic Corporation
Hazard
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Sold states
Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
Affected count
7,490 units
Manufactured in
219 Sowon-Ro; Deogyang, Goyang, Korea (the Republic of)
Products
XERF EFFECTOR 60. Electrosurgical unit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2026Don't want to check this manually?
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