FDA Green Lights Repair and Replacement Program for Philips’ DreamStation Recall

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Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification. The vast majority of the registered affected devices—more than 80%—are from the first-generation DreamStation product family, and more than half of the recalled devices across the globe are located in the United States. A list of devices can be found here.

Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to restore affected first-generation DreamStation devices by replacing the PE-PUR sound abatement foam with a new material. The company anticipates the rework to begin this month. Philips Respironics is initiating its repair and replacement program in other countries and expects the program to be underway in most markets by the end of September 2021. The company intends to complete its repair and replacement programs within approximately 12 months. 

According to a statement from the CEO of Philips, Frans van Houten, [Philips Respironics] “fully recognize[s] that the timeframe for remediation of the affected devices places patients in a difficult situation.” 

“We are mobilized to deliver a solution to them as fast as possible,” van Houten said. “We have significantly increased our production, service, and rework capacity, and further intensified our outreach to our customers and their patients.”

Mr. van Houten urged patients with “affected active devices” to register their machine on the recall notification site. Patients with affected devices currently in use must register their products on the recall notification site to facilitate the repair and replacement program. You can get more information about registering your device here and view step-by-step instructions for locating the serial number on your device(s) here.

CPAP.com remains in close communication with Philips Respironics surrounding recall updates and is dedicated to each of our customers to ensure continued care throughout your sleep apnea journey. 

More information, including instructions for current Philips Respironics users, can be found here.