Official recall record
Clarity II Main System Body
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-01-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.