Omnilab Advanced and BiPAP A40
Brand(s)
Last updated
Summary
Product
Omnilab Advanced and BiPAP A40
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
Affected products | Lot or serial number | Model or catalog number |
---|---|---|
Omnilab Advanced, Domestic Core | L28664722DB58 L28664717A69D | 1111124 |
Bipap A40, Canada, Core Package | More than 10 numbers, contact manufacturer. | 1111174 |
Issue
As a result of a supplier notification, Philips determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. If the non-conforming plastic is present in the device motor, it could lead to off-gassing that would not occur in a device within specification. The presence of non conforming plastic could lead to structural failure causing the immediate and sudden failure of the device during use.
Recall start date: August 26, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Respironics Inc.
1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64502
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