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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