CHESTCHEST NewsWhat You Need to Know About the Philips PAP Device Recall

What You Need to Know About the Philips PAP Device Recall

Recent updates: In November 2021, Philips updated the guidance in its June 14, 2021, U.S. recall notifications for certain CPAP, BiPAP, and mechanical ventilator devices to align them with the Food and Drug Administration’s recommendations. CHEST continues to monitor the situation as it develops and is actively engaging with Philips and partner associations on behalf of you and your patients.

Available resources and guidance

Philips Recall Notification (Updated November 2021)

Philips is now encouraging BiPAP/CPAP users to work directly with their health care providers before making any change to their therapy. The updated recall notification no longer calls for patients to immediately discontinue use of the recalled BiPAP/CPAP devices prior to discussing with their health care providers. The updated advice better enables shared decision-making among patients and providers to assess risks and benefits.

Philips Statement on Recall and Replacement Program

Philips has released details on its process to replace the PE-PUR sound abatement foam in affected first-generation DreamStation devices, as well as to replace certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices.

Device Registration Process

Patients with affected devices should register their devices with Philips.

FDA Safety Communication

The US Food and Drug Administration has issued recommendations for patients, health care providers, and facilities.

AASM Resource Page

The American Academy of Sleep Medicine (AASM) offers guidance for clinicians, such as sample patient communications, clinical assessment tools, webinar recordings, and more.

Position Statement: Canadian Thoracic Society, Canadian Sleep Society, and Canadian Society of Respiratory Therapists

These societies have provided guidance to physicians and medical device distributors with regard to the recent recall notice.

Clinician infographic

CHEST has compiled information for clinicians on what approach to use for patients whose devices may be part of the Philips recall, emphasizing shared decision-making between patients and their health care providers.

Philips Recall of CPAPs, BiLevel PAPs, & Home Ventilators infographic
Philips recall infographic

For your patients

CHEST’s Sleep Medicine Network has created an easy reference sheet to help patients understand what steps to take, potential health risks, insurance information, and recommendations from Philips.