Health product recall

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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