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Omnilab advanced and bipap a40

Official notice

31 Aug 2022

Last checked

31 Aug 2022

Critical riskHealth Canada

An official Health Canada notice concerns Omnilab advanced and bipap a40. 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 Published 2022-08-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64502

Official notice

2022-08-31

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64502

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Affected products

Product 1

Affected products - Omnilab Advanced, Domestic Core, Lot or serial number - L28664722DB58 L28664717A69D, Model or catalog number - 1111124

Product 2

Affected products - Bipap A40, Canada, Core Package, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 1111174

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Respironics, Omnilab Advanced And Bipap A40.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

64502

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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