Recall Monitor
Health Products

Clarity II Main System Body

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Clarity II Main System Body
Issue: Medical devices - Performance
What to do: Customers to be contacted by manufacturer.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Clarity II Main System BodySN: 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

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