Recall Monitor
Health Products

Alice Le System - Sleepware Software

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: Alice Le System - Sleepware Software
Issue: Medical devices - Unauthorised device
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Alice Le System - Sleepware Softwarev4.0.1.01031854
Alice Le System - Sleepware Softwarev4.0.2.01031854
Alice Le System - Sleepware Softwarev4.0.0.01031854

Issue

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.

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