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Philips reports possible safety issue

Philips reports possible safety issue As a result, the company has taken a provision of EUR 250M

CAMBRIDGE, Mass. – Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of the company’s sleep and respiratory care devices. 

“The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone, and certain environmental conditions involving high humidity and temperature,” the company stated in a regulatory update that was part of its first quarter highlights

The majority of affected devices are in the first-generation DreamStation product family. 

Philips’ recently launched next-generation CPAP platform, DreamStation 2, in not affected. 

“Philips is in the process of engaging with the relevant regulatory agencies regarding this matter and initiating appropriate actions to mitigate these possible risks,” the company stated. “Given the estimated scope of the intended precautionary actions on the installed base, Philips has taken a provision of EUR 250 million.” 

Two years ago, Philips, along with other manufacturers of CPAP devices, said that using ozone to clean and sanitize their products may affect warranties.  


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