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The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.
This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. However, this new recall does apply to some of the devices recalled in June 2021.
Philips distributed 386 affected BiPAP machines in the U.S. between August 6, 2020, and September 1, 2021. On August 26, 2022, Philips sent affected customers, including Durable Medical Equipment (DME) suppliers, an Urgent Medical Device Recall letter. The models, some of which are intended for use only in clinical environments, are listed below; however, only machines with the serial numbers identified in the company’s Urgent Medical Device Recall letter are affected by this recall.
Recommendations for Patients and Caregivers
Locate all recalled devices in your facility.
If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, we encourage you to report any health issues or problems with the device through the MedWatch Voluntary Reporting Form.
At Home or in clinical environments
By adult and pediatric patients
With obstructive sleep apnea syndrome or respiratory insufficiency
No action, if the device was corrected or replaced through the June 2021 recall, as the affected plastic components were also replaced.
If the device was not already corrected or replaced through the June 2021 recall, register the device on the Philips website, if not done already, and talk with your health care provider to decide if the plan for your care and treatment should change as a result of this recall.
At Home or in clinical environments
By adult and pediatric patients
With obstructive sleep apnea syndrome, respiratory insufficiency, or respiratory failure
No action, if the device was corrected or replaced through the June 2021 recall, as the affected plastic components were also replaced.
If the device was not already corrected or replaced through the June 2021 recall, register the device on the Philips website, if not done already, and talk with your health care provider to decide if the plan for your care and treatment should change as a result of this recall.
By adult and pediatric patients
With obstructive sleep apnea syndrome or respiratory insufficiency
By adult and pediatric patients
With obstructive sleep apnea syndrome or respiratory insufficiency
A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model.
The Philips Respironics BiPAP machines included in this recall may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.
The potential risks of inhaling VOCs include:
If the plastic causes the machine to fail and stop working suddenly, it may lead to serious injury or death.
The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue.
The FDA recognizes that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner. We continue to work with Philips to assure that the company takes appropriate steps to correct the products.
For this recall, as with recalls in general, the FDA is reviewing the strategy the company proposes to address the problem, assessing the health hazard presented by the product, determining if the problem violates FDA law or involves potential violations of FDA requirements, and if appropriate, assigning the recall a classification (I, II, or III) to indicate the relative degree of risk.
Though this recall is not associated with the foam issue described in Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, the FDA continues to carefully evaluate the totality of information available to the FDA in determining appropriate next steps.
The FDA will keep the public informed if significant new information becomes available.
If you have a health issue, including those listed under potential health risks, or any problem with your BiPAP machine, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com.
More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.