PHILIPS RESPIRONICS RECALL NOTICE & UPDATES

Updated as of 9/1/2021

9/1/2021: Philips Respironics issued a press release indicating that the repair and replacement program of first-generation DreamStation devices in the US has started, and that the new sound abatement foam has been approved by the FDA. Philips Respironics intends to complete the repair and replacement programs within approximately 12 months. 

8/12/2021: Philips Respironics provided supplemental clinical information for the use of bacteria filters. 

7/29/2021: The US Food & Drug Administration (FDA) develop and publish a Philips Respironics Recall FAQ. 

7/8/2021: Philips Respironics provided supplemental clinical information for physicians regarding the recall.

6/28/2021: The DME MACs, who process Medicare Durable Medical Equipment, Orthotics, and Prosthetics (DMEPOS) claims for a defined geographic area/jurisdiction, develop and publish a Philips Respironics Recall FAQ. 

6/14/2021: On June 14, 2021, Philips Respironics issued a voluntary recall notification for their Continuous Positive Airway Pressure (CPAP) and Bi-level Positive Airway Pressure (BiPAP) machines due to potential health risks related to the sound abatement foam used in their respective devices. 

Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. They have established a registration portal and support center to assist you.

 

If Nationwide Medical, Inc. supplied you with your machine, we submitted your device information to Philips Respironics to start the registration process.

 

However, your action is still required; Philips Respironics requires that each patient registers directly in order to process the replacement device. 

 

Submit your registration online or call (877) 907-7508.

You will need to provide your device serial number and current contact information.

Video instructions on how to register - YouTube

Although we are not responsible for the Philips Respironics recall, we want to support our patients through this difficult time. We have been working diligently with Philips Respironics to ensure our patients receive continual updates. As we learn more, we will update our website here. Or, contact us to learn more.

 

Sincerely,

Nationwide Medical, Inc.