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Clarity ii main system body

Official notice

29 Jan 2025

Last checked

29 Jan 2025

High riskHealth Canada

An official Health Canada notice concerns Clarity ii main system body. 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 Published 2025-01-29.

What to do now

Customers to be contacted by manufacturer.

Recall number

76871

Official notice

2025-01-29

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76871

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Affected products

Product 1

Affected products - Clarity II Main System Body, Lot or serial number - SN: C3024G039 SN: C3024G029 SN: C3024H054 SN: C3024G032 SN: C3024H051 SN: C3024G034 SN: C3024G035 SN: C3024G030, Model or catalog number - Not applicable.

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Lutronic, Clarity Ii Main System Body.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

high

Recall details

Recall number

76871

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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