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Philips bipap and humidifiers
Official notice
10 Jul 2023
Last checked
10 Jul 2023
An official Health Canada notice concerns Philips bipap and humidifiers. There is currently a non-conformance regarding the disinfection method recommended in the instructions manual for devices in the field, as the Keredusy disinfection method was not adequately validated. Long term effects of this method on the device components are unknown. Full validation requires biological evaluation after cleaning cycles per ISO 10993-1 and testing on expected worse-case clinical use per ISO 18562-1. The maximum number of Keredusy cycles was also not identified within the user manuals. ISO 17664-1 does allow for the manufacturer's IFU to direct the processor to refer to the disinfecting agent manufacturer's IFU with reference to concentration, temperature, and contact time, but these parameters were not defined nor documented within the IFU. The IFU only directed the user to Philips customer service. Recall Start Date: June 30, 2023 Published 2023-07-10.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73914
Official notice
2023-07-10
The hazard
The hazard
There is currently a non-conformance regarding the disinfection method recommended in the instructions manual for devices in the field, as the Keredusy disinfection method was not adequately validated. Long term effects of this method on the device components are unknown. Full validation requires biological evaluation after cleaning cycles per ISO 10993-1 and testing on expected worse-case clinical use per ISO 18562-1. The maximum number of Keredusy cycles was also not identified within the user manuals. ISO 17664-1 does allow for the manufacturer's IFU to direct the processor to refer to the disinfecting agent manufacturer's IFU with reference to concentration, temperature, and contact time, but these parameters were not defined nor documented within the IFU. The IFU only directed the user to Philips customer service. Recall Start Date: June 30, 2023
How to check if you're affected
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.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Philips.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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