Product Recall for Philips BiLevel PAP, CPAP Devices and Mechanical Ventilators

Posted on 2021-07-06
Updated on 2021-07-06 09:00:00

CareFirst BlueCross BlueShield and CareFirst BlueChoice, Inc. (CareFirst) has been made aware of the potential health risks related to sound abatement foam used in specific Philips Respironics Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) and Mechanical Ventilators. We encourage our members and providers to follow the processes and reminders as outlined by Philips.

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

Important Note: Affected devices 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.

Members should follow Philips’ established registration process to determine if their device is impacted. They will be able to look up their device serial number and begin a claim if their device is affected. Also, Philips is recommending that members stop using ozone cleaning products and follow their devices approved cleaning methods found in the instructions.

We are instructing our members to work with you to determine the most appropriate treatment options, which, for some individuals, may include stopping treatment and registering for a replacement device.

For DME Providers

If you are a DME provider, distributor or medical institution, you should start the registration process to be part of Philips’ repair and replacement program. Providers may receive a letter from Philips with login information. If you haven’t received a letter, use the link here to get started.

Additional Information

For more information on the recall notice, including a complete list of impacted products, and potential health risks, view Philips Respironics’ press release at philips.com/src-update. You can also view the FDA’s announcement here.

For questions, please contact your Provider Relations Representative.