Alice Le System - Sleepware Software
Last updated
Summary
Product
Alice Le System - Sleepware Software
Issue
Medical devices - Unauthorised device
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Alice Le System - Sleepware Software | v4.0.1.0 | 1031854 |
| Alice Le System - Sleepware Software | v4.0.2.0 | 1031854 |
| Alice Le System - Sleepware Software | v4.0.0.0 | 1031854 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Respironics Inc. Also Trading As Philips Rs North America LLC
1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82294
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