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Health Canada Medical devices

Omnilab Advanced and BiPAP A40

Issued August 31, 2022
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
Hazard description
Performance
Product
Product name
Omnilab Advanced and BiPAP A40
Reference
ID
RA-64502