Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

Important information for clinicians

We are fully committed to partnering with you to support your patients. 


Together with five independent, certified testing laboratories and third-party experts, Philips Respironics has conducted extensive testing since June 2021. Based on the results to date, Philips Respironics and the third-party experts concluded that use of the sleep therapy devices is not expected to result in appreciable harm to health in patients. Further testing related to the sleep therapy and ventilator devices remain ongoing. Following ongoing communications, Philips Respironics agreed in October 2023 to the FDA’s recommendations to implement additional testing on the sleep and respiratory care devices to supplement current test data. Philips Respironics is in discussions with the FDA on the details of further testing. 


Since the start of the test and research program, Philips Respironics has worked cooperatively with the FDA on the program and to publish regular test updates as agreed with the FDA. The latest update can be found here.

 

As we continue to make progress on the remediation of CPAP, BiPAP and ventilator devices it is important that you are informed on the latest updates. We will continue to update our remediation progress page throughout the process. 

Ventilation information

Lung icon

The remediation of the ventilator devices remains ongoing. Philips Respironics will communicate with Durable Medical Equipment providers (DMEs) as updates become available. Please visit our ventilation news and updates page for the latest information.

Sleep therapy remediation progress updates

Sleep icon

We have first-generation DreamStation and DreamStation2 devices available to ship and are asking customers and clinicians to help us to remind patients that they may need to take a specific action in the Patient Portal to receive their replacement device.


Some patients may have the option to choose a replacement device with Auto-adjusting CPAP settings if we have been unable to obtain their updated prescription settings. Learn more about Auto-adjusting CPAP options for your patients here.

DreamStation 2

Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device.

The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced.

Latest updates

Philips provides update on Respironics recall

October 6, 2023

Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice

September 27, 2023

The latest information for you and your practice

 

Our clinical bulletins have been created to help update physicians on recent developments as well as provide a status update on remediation efforts.

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