Health product recall

ETHEREA-MX® System

Last updated

Summary

Product
ETHEREA-MX® System
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

IPL Filter 540nm

All lots.

011284

ER:YAG DualMode® Laser Handpiece 2940nm

All lots.

018091

ETHEREA-MX® System

All lots.

018058

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
Companies

Vydence Medical - Indústria e Comércio Ltda.

Aldo Germano Klein 359, Sao Paulo, Brazil, 13573-470

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74502

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