Health product recall

Clarity II Main System Body

Last updated

Summary

Product
Clarity II Main System Body
Issue
Medical devices - Performance
What to do

Customers to be contacted by manufacturer. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Clarity II Main System Body

SN: C3024G039
SN: C3024G029
SN: C3024H054
SN: C3024G032
SN: C3024H051
SN: C3024G034
SN: C3024G035
SN: C3024G030

Not applicable.

Issue

A small number of clarity ii devices with a software bug that affects the "skin temp" feature has been identified. This feature is used during laser toning treatment and actively displays the temperature of the patient's skin being treated to the clinician on the gui of the screen. A situation was identified where specifically, the 'skin temp' was not updating during treatment..  This may increase the probability of a patient injury or burn.

Recall start date: December 30, 2024

Additional information

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

Lutronic Corporation

Lutronic Center, Goyang-Si, Gyeonggi-Do, South Korea, 412-220

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76871

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