Clarity II Main System Body
Brand(s)
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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