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Health Canada Medical devices

ETHEREA-MX® System

Issued October 31, 2023
Issue
Incorrect user manual sent with the system. Indications from outside Canada that were not part of Health Canada submission. Salient's trainer noticed anomaly during training. Indications for Intense Pulsed Light (IPL) use for tattoo removal and melasma, and 2940nm for tumour removal. Recall start date: June 23, 2021
Hazard description
Labelling and packaging
Product
Product name
ETHEREA-MX® System
Reference
ID
RA-74502