Original Post
Date Issued: August 29, 2022
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.
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
Recommendations for Patients and Caregivers
- The A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) machines were also included in the June 2021 recall issued by Philips Respironics. If you have an A-Series BiPAP A30 (Ventilator) or A-Series BiPAP A40 (Ventilator) machine:
- No action is needed, if your device was corrected or replaced through the June 2021 recall, as the affected plastic components were also replaced.
- If your device was not already corrected or replaced through the June 2021 recall, register your device on the Philips website if you have not done so 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.
- If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk with your health care provider and report the issue or problem through the MedWatch Voluntary Reporting Form.
Recommendations for Health Care Providers
Locate all recalled devices in your facility.
- The A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines, which are intended for use only in clinical environments, are not a part of the June 2021 recall issued by Philips Respironics. Replace these devices with an unaffected device or discuss with your patient (or their caregiver, as appropriate) whether their plan for care and treatment should change as a result of this recall.
- The A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) machines, which are intended for use in either clinical environments or by patients at home, were also included in the June 2021 recall issued by Philips Respironics. For health care providers who have patients using an A-Series BiPAP A30 (Ventilator) or A-Series BiPAP A40 (Ventilator) machine:
- No action is needed if the device was already 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, if not done already, on the Philips websiteExternal Link Disclaimer and discuss with your patient the best treatment course.
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.
Summary of FDA Recommendations
| Device | Used | Recalled | What to Do |
|---|---|---|---|
| A-Series BiPAP A30 (Ventilator) | At Home or in clinical environmentsBy adult and pediatric patientsWith obstructive sleep apnea syndrome or respiratory insufficiency | For plastic issue in Aug 2022 and for foam issue in June 2021 | 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 websiteExternal Link Disclaimer, 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. |
| A-Series BiPAP A40 (Ventilator) | At Home or in clinical environmentsBy adult and pediatric patientsWith obstructive sleep apnea syndrome, respiratory insufficiency, or respiratory failure | For plastic issue in Aug 2022 and for foam issue in June 2021 | 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 websiteExternal Link Disclaimer, 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. |
| A-Series BiPAP V30 (Auto Ventilator) | Only in clinical environmentsBy adult and pediatric patientsWith obstructive sleep apnea syndrome or respiratory insufficiency | For plastic issue in Aug 2022 | Replace these recalled devices with another unaffected device or discuss with your patient (or their caregiver, as appropriate) whether their plan for care and treatment should change as a result of this recall. |
| OmniLab Advanced+ | Only in clinical environmentsBy adult and pediatric patientsWith obstructive sleep apnea syndrome or respiratory insufficiency | For plastic issue in Aug 2022 | Replace these recalled devices with another unaffected device or discuss with your patient (or their caregiver, as appropriate) whether their plan for care and treatment should change as a result of this recall. |
Device Description
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.
Contaminated Plastic in Certain Philips BiPAP Machines
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:
- Headache
- Dizziness
- Irritation in the eyes, nose, respiratory tract (airway), and skin
- Hypersensitivity reaction, such as an allergic reaction or another immune system reaction
- Nausea or vomiting
- Toxic and cancer-causing effects
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.
FDA Actions
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.
Reporting Problems with Your BiPAP Machine
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.
Questions?
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 [email protected].
More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.
