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Reusable Non-Invasive Radio Frequency Electrode
- Starting date:
- June 21, 2017
- Posting date:
- July 17, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63982
Reason
The RFE-10-D electrode was removed from the system licence on June 1, 2017. Thermi is in the process of obtaining a new device licence in Canada and intends to restart sale of the device to Canada once the renewal licence in approved. The recall is not related to device defectiveness. There have been no reported adverse events related to this device in Canada.
Affected products
Reusable Non-Invasive Radio Frequency Electrode
Lot or serial number
All (2014-03-08 to 2017-04-21)
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Thermiaesthetics, LLC DBA Thermiaesthetics DBA Thermi
8304 Esters Blvd., Suite 890
Irving
75063
Texas
UNITED STATES