Explained: The voluntary Philips Respironics sleep and
respiratory care devices recall*
respiratory care devices recall*
You may have heard about the Philips Respironics recall* related to certain sleep and respiratory care devices, and you may have questions about what this is, why a notice has been issued and how long the remediation process will take.
You may have heard about the Philips Respironics recall* related to certain sleep and respiratory care devices, and you may have questions about what this is, why a notice has been issued and how long the remediation process will take.
* This is a voluntary recall notification in the US and field safety notice in other countries
Patient safety and quality remains our top priority. We understand how important Philips Respironics sleep and respiratory care devices are to patients who use them. Philips Respironics acted to protect patient safety by initiating and executing a voluntary recall* of significant scale in June 2021. Philips regrets any distress and concern this recall* has caused patients, their families and care providers. We deeply apologize for this and continue to dedicate all necessary resources to ensure that impacted patients receive remediated devices.
To provide further information on the recall* we have outlined below answers to a number of questions, along with links to where you can find more detailed information.
If you are a patient, business customer or a clinician,
please visit this page for more information.
If you are an investor or financial analyst,
please visit this page for more information.
please visit this page for more information.
If you are an investor or financial analyst,
please visit this page for more information.
What is Philips Respironics? A sleep therapy device, also known as a Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) device, is designed to deliver air pressure when you breathe in and out. Although the functionality of CPAP and BiPAP devices differ, they are both used to treat sleep-related breathing disorders, including sleep apnea which is estimated to affect close to one billion people globally. The Philips Respironics respiratory portfolio also includes ventilator devices, which are used across both hospital and home care settings. These ventilators provide assisted ventilation and are intended to support the breathing of patients who suffer from conditions that make it hard for them to breathe.
Philips’ subsidiary, Philips Respironics, is a global leader in sleep and respiratory care. Founded in 1976 and originally named Respironics, Inc., the company was acquired by Philips in 2008, and in 2020, its legal name changed to Philips RS North America LLC. For over 40 years, Respironics has been supporting the community of patients who rely on its sleep and respiratory care solutions for their health and quality of life.
What is a sleep therapy device, and why do people need them?
What is a ventilator device, and why do people need them?
Why did Philips Respironics issue a voluntary recall notification in the US and field safety notice in other countries?
In June 2021, Philips initiated a voluntary recall notification / field safety notice for certain CPAP and BiPAP sleep therapy devices and mechanical ventilators to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. You can find the full list of affected devices here and the full notification is available to read here.
Why did Philips Respironics use polyester-based polyurethane (PE-PUR) sound abatement foam in certain of its sleep and respiratory care devices?
Philips Respironics used this foam to reduce sound and vibration in certain of its CPAP, BiPAP and ventilator devices. These medical devices were designed to meet all relevant standards at the time of development and launch.
When was it discovered that there were potential risks that ultimately led to the recall*? In the years prior to 2021, complaints related to possible PE-PUR foam degradation were investigated, evaluated, and addressed by Philips Respironics primarily on a case-by-case basis. When Philips became aware of the issue and its potential significance in early 2021, Philips and Philips Respironics took actions that led to the voluntary recall* in June 2021. Although Philips and Philips Respironics only had a limited amount of information regarding the potential health risks, the recall decision was made in an abundance of caution, after careful consideration of a reasonable worst-case scenario, rather than deferring the recall decision to conduct more definitive testing. That additional testing occurred after the recall announcement, as discussed below. Has Philips Respironics conducted further testing and analysis on the affected devices? 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 remains 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. Have other parties studied the health effects of Philips sleep therapy devices? Yes, independent of Philips Respironics, 13 epidemiological studies found no association between use of PAP devices, including Philips Respironics PAP devices, and increased risk of cancer in patients with obstructive sleep apnea.
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.
Facts and figures
For more than
40 years
Respironics has provided sleep and respiratory care devices to patients
Patient safety and quality is Philips’ #1
priority
More than 99%
of the sleep therapy device registrations that are complete and actionable have been remediated
Together with 5 independent, certified testing laboratories and 3rd-party experts, Philips Respironics has conducted extensive testing
Philips Respironics has sufficient inventory and manufacturing capacity to satisfy any current or forecasted new sleep therapy device registrations in a timely manner
For more than
40 years
Respironics has provided sleep and respiratory care devices to patients
Patient safety and quality is Philips’ #1
priority
Philips Respironics has sufficient inventory and manufacturing capacity to satisfy any current or forecasted new sleep therapy device registrations in a timely manner
More than 99%
of the sleep therapy device registrations that are complete and actionable have been remediated
Together with 5 Philips Respironics has conducted extensive testing
independent, certified testing laboratories and 3rd-party experts,
What is the remediation of the affected devices about? The remediation focuses on the replacement of the PE-PUR sound abatement foam with the new silicone sound abatement foam through a comprehensive repair involving the replacement of several components or a replacement of the device. How long is the remediation of all affected devices expected to take? What is meant by a ‘complete and actionable’ registration? Complete and actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information. For example, the necessary information for patients who elect to receive a remediated device includes physician information, complete prescription, or election to receive an auto-adjusting PAP device. Philips Respironics will continue to prioritize existing and new registrations as the remediation team receives the information needed to action those registrations. Philips Respironics has existing inventory and manufacturing capacity to satisfy any remaining or forecasted new sleep therapy device registrations in a timely manner. Philips Respironics has sufficient inventory and manufacturing capacity to satisfy any current or forecasted new sleep therapy device registrations in a timely manner. With awareness of the relevant competent authorities, Philips Respironics gradually started serving new patients with selected sleep therapy devices (with the new silicone sound abatement foam) in various countries. This measured approach will help to make these necessary devices more readily available in these countries, while still honoring the commitment to seeing remediation efforts through to completion. Philips Respironics is not currently serving new patients with sleep therapy devices in the US. How is Philips’ relationship with the FDA and other competent authorities? Philips shares the same objectives as the FDA and other competent authorities to ensure patient safety and quality in the delivery of healthcare and to drive innovation. We are therefore committed to working closely with these agencies. Is the DreamStation 2 CPAP device safe to use? Yes, the DreamStation 2 CPAP device can safely be used when the instructions for use for the DreamStation 2 device are followed.
The CPAP and BiPAP sleep therapy devices represent most of the devices under the recall*. To date, more than 99% of the sleep therapy device registrations globally that are complete and actionable have been remediated. Patients with any remaining sleep therapy device currently in use that has not been remediated and is not registered, are requested to register their product to facilitate the remediation of their devices. The remediation of affected ventilators remains ongoing in coordination with the relevant competent authorities.
Is Philips Respironics selling devices to new patients?
Are Philips Respironics devices with the new silicone sound abatement foam safe to use?
Yes, Philips Respironics’ devices with silicone sound abatement foam have been subject to extensive testing in accordance with the applicable industry testing standards, and Philips Respironics has not identified any safety issues. Silicone is a rubber-like material that is also used for bakeware.
The CPAP and BiPAP sleep therapy devices represent most of the devices under the recall. To date, more than 99% of the sleep therapy device registrations globally that are complete and actionable have been remediated. The remediation of affected ventilators remains ongoing in coordination with the relevant competent authorities. The repair and replacement program, which involves up to 5.6 million devices, is an undertaking of significant scale. In an average year, Philips Respironics produces and distributes around one million sleep devices. The increase of the production capacity was impacted by the supply chain challenges in 2021/2022, such as component and freight capacity shortages. Nevertheless, Philips Respironics was able to increase the production capacity by more than a factor of three. In certain cases, to enable the easiest and most familiar replacement option, we delivered a CPAP main blower motor module that would work with their existing humidifier and power cord supply; in other situations, the needs of the patient were best served by delivering a complete set-up including the blower motor along with compatible humidifier and other accessories.
What is the status of the repair and replacement program to date? If there were delays, what caused them?
Customers have complained about getting refurbished machines that were missing parts. Can you explain?
The Philips Respironics CPAP patient population related to the recall* covered several versions of our CPAP platforms. To optimize matching speed and the best possible option to transition the patient to a replacement device, the repaired or new replacement device the patient received came in a variation of configurations.
* This is a recall notification in the US and field safety notice in other countries
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