Public recall detail

Alice Le System - Sleepware Software

2026-07-08

medium
Health products Health product recall
Quick summary

Quick summary: Alice Le System - Sleepware Software. Reason: Health product recall. Category: Health products. Date: 2026-07-08.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Alice Le System - Sleepware Software. Reason: Health product recall. Category: Health products. Date: 2026-07-08.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandRespironics Inc. Also Trading As Philips Rs North America Llc
ProductAlice Le System - Sleepware Software
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-82294

Affected products

ProductAlice Le System - Sleepware Software
Lotv4.0.1.0
Model1031854
Serial numberv4.0.1.0
DescriptionAlice Le System - Sleepware Software
ProductAlice Le System - Sleepware Software
Lotv4.0.2.0
Model1031854
Serial numberv4.0.2.0
DescriptionAlice Le System - Sleepware Software
ProductAlice Le System - Sleepware Software
Lotv4.0.0.0
Model1031854
Serial numberv4.0.0.0
DescriptionAlice Le System - Sleepware Software

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesRespironics Inc. Also Trading As Philips Rs North America LLC1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
Recall date2026-06-25
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82294
Background{}
CompaniesRespironics Inc. Also Trading As Philips Rs North America LLC1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
AudiencesHealthcare
Source updated2026-07-08

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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