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Health Canada Health products

Alice Le System - Sleepware Software

Issued June 25, 2026
Issue
Product Alice Le System - Sleepware Software Issue Medical devices - Unauthorised device What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
Philips Respironics has become aware of a compliance issue with Sleepware G3 versions 4.0.0.0 and above, where the original 4.0 update was not licensed appropriately in Canada for a significant change in the software from the previous version. Therefore, all versions of Sleepware G3 distributed in Canada of versions 4.0.0.0 and above are not licensed for distribution in Canada.
Reference
ID
RA-82294