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Important Philips Respironics Voluntary Product Recall in Effect

Official statement by Philips Respironics:

“As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

The recall notification (U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.

Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue.

Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material,  or repaired to replace the sound abatement foam in customer units. The new material will also replace the current sound abatement foam in future products.

For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.   

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device instructions for Use for approved cleaning methods”.  

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. 

To determine whether you qualify for a replacement machine with ADP (Assistive Devices Program of Ontario) funding, your machine should be over 5 years of age, since last going through the government for funding.  Should your machine meet this specific criteria, please contact your prescribing sleep specialist to obtain advice as to whether you should replace your product.   

For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit: philips.com/SRC-update

The following machines are included in the Philips recall…..

CPAP and BiLevel PAP Devices & all affected devices manufactured before 26 April 2021. All Device Serial Numbers are included in the Philips Recall.

Please visit Philips website to register your CPAP machine online to register your machine. By registering online, Philips will be in touch with you directly to arrange for any repairs/replacement units.  They will request the serial number of your CPAP machine which is located at the back of your machine.

Alternatively, should you not have access to email, please contact Philips directly at 1-877-907-7508

The following machines are included in the Philips recall…..

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers are included in the Philips Recall.

Remstar

Remstar CPAP Pro – System One

Dreamstation

Dreamstation CPAP / CPAP Pro/ APAP/ BIPAP / EXPERT

Dreamstation-Go

Dreamstation Go

Remstar-SE

Remstar SE – M Series

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