Philips Respiratory Products Recall - News & Resources

On June 14, 2021, Philips announced a voluntary recall pertaining to certain ventilators and devices used to treat obstructive sleep apnea, including CPAP and BiPAP devices. These products are being recalled due to issues with sound abatement foam used in the devices.

AAHomecare will continue to work with respiratory stakeholders, clinical groups, government entities and their contractors, and major payers to help expedite replacement equipment and continue high-quality care for patients who continue to use their devices in the near term.

RESOURCES FOR Patients & caregivers

Consumers can see guidance from Philips and the U.S. Food and Drug Administration for details on the specific devices affected and advice on continuing to use these products. Patients using these devices are encouraged to register their devices with Philips to begin a claim and help provide useful data on the total number of devices affected.  The registration link can be found under the "Patients, Users, and Caregivers" heading on the Philips recall site and accessed directly here.

NEWS, UPDATES & GUIDANCE

Philips Medical Device Notification - Includes guidance for DME suppliers, distributors, medical institutions; patients, users and caregivers; and physicians/other medical care providers.

Philips press release: Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification (Sept. 1, 2021)

AAHomecare Alert: CMS Notice to Patients on Respiratory Recall Significantly Lacking in Context (Aug. 25, 2021)

AAHomecare letters on recall-related DME supplier perspectives to Medicaid programs and payers (July 9, 2021)

FDA Safety Communication on Recall (June 30, 2021)

AAHomecare Letter to DME MACs (June 29, 2021) - Letter requests that DME MACs work with HME community by continuing to reimburse for this equipment and related supplies for patients who continue to use them, as well as asking for a temporary suspension of time-specific adherence rules to allow patients time to have devices repaired or replaced.

DME MAC Jurisdiction A FAQ on Recall (June 25, 2021) - developed in concert with Jurisdiction D, who issued identical guidance.