ETHEREA-MX® System
Summary
Contact the manufacturer if you require additional information.
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
Vydence Medical - Indústria e Comércio Ltda.
Aldo Germano Klein 359, Sao Paulo, Brazil, 13573-470
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