Lutronic Corporation: XERF EFFECTOR 60. Electrosurgical unit.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Lutronic Corporation
- Product
- XERF EFFECTOR 60. Electrosurgical unit.
- Reason / hazard
- Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-09-04
- Code info
- Model/Catalog Number: 1101210000, 1101210100, 1101210200; UDI: 08809447657752, SERIAL/LOT: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, and MP60J25H01. Devices manufactured from 04/01/25 to 08/20/25.
- Product quantity
- 7,490 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Goyang
- Country
- Korea (the Republic of)
- Event id
- 97620
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