Philips Recall

Our patients who are using a Philips BiLevel Positive Airway Pressure or Continuous Positive Airway Pressure device for treatment of a sleep disorder should have already heard from Philips, who has issued a recall of many of their CPAP and BiLevel PAP devices and mechanical ventilators. This is due to possible degradation of sound abatement foam and exposure to chemical emissions from the degraded foam material. High heat and humidity as well as use of unapproved cleaning methods, such as ozone (e.g. SoClean, PrimeClean), may contribute to foam degradation.

Philips has excellent information on their web site regarding their efforts to rectify the issue as well as answers to questions. They offer a registration process which allows patients to look up their device serial number and begin a claim if the unit is affected. We encourage anyone using a Philips device to use the registration process.

We are following recommendations from the American Academy of Sleep Medicine and the American Thoracic Society with regard to use of the affected devices. For patients using life-sustaining mechanical ventilator devices, we would recommend that you do not stop or alter prescribed therapy until after talking to your physician. Appropriate therapeutic decisions need to balance risks of continuing therapy versus temporarily discontinuing the device while awaiting a reasonable alternative.

For our patients on Bi-level PAP and CPAP devices who have severe breathing difficulties or were very sleepy during the daytime before treatment, have chronic obstructive pulmonary disease (COPD), cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that you not stop your prescribed therapy until your unit is replaced or repaired. Philips advises patients use an inline bacterial filter with your unit in the meantime.

For our other patients using Bi-level PAP and CPAP devices, contact your physician or DME provider to determine the most appropriate option for continued treatment. The determination will be based on the severity of your sleep disorder, the availability of an alternate device (durable medical equipment suppliers, including Texas Pulmonary, have very limited inventory), as well as other possible treatment methods, such as positional therapy or oral appliance therapy.

As noted above, if you need to continue use of an affected device, do not use unapproved cleaning methods and keep your device away from high heat and humidity.

Frequently Asked Questions:
(Also see the Questions and Answers section of Philips' site.)

Q. What is the risk to the patient associated with using a recalled device during one night for an in-lab titration?
A. Based on the information currently available from Philips, this risk is unknown.

Q. What is the risk to regular users of recalled PAP machines?
A. Philips has reported that the complaint rate in 2020 was low (0.03%). However, it is unknown how many cases may have been unreported.

Q. Should filters be used with a recalled device?
A. According to Philips, if physicians determine that a patient must continue using a life-sustaining mechanical ventilator device, patients are strongly urged to use an approved bacterial filter per Instructions for Use; it may reduce exposure to degraded sound abatement foam particles, though bacterial filters will not reduce exposure to potential volatile organic compounds (VOCs). Contact your DME supplier to identify the appropriate filter for your device. Philips has made no public recommendation for or against the use of filters with recalled BPAP and CPAP devices.

Q. I have an affected device and need to continue using it. Where can I get an in-line bacterial filter?
A. Texas Pulmonary does not have the in-line bacterial filters available, but they can be obtained from a number of online suppliers (Amazon, CPAP.com, etc.)

Q. Do other PAP manufacturers use the same foam found in the recalled Philips devices?
A. An online statement from ResMed indicates that, “ResMed devices are not subject to this recall and are safe for patients to use. ResMed devices use a different material for sound reduction than the material used by Philips.”

Q. How long will it take for Philips to repair and replace the recalled devices?
A. At this time, Philips has not disclosed a timeline to repair and replace recalled devices. However, because the recall involves millions of PAP devices, it may take some time before this process is complete. Philips has stated that it will replace the current sound abatement foam with a new material after obtaining relevant regulatory clearances. Philips also has indicated that they will address all affected devices in the scope of this correction as expeditiously as possible.

Please follow the Philips web site (https://www.usa.philips.com/healthcare/e/sleep/communications/src-update) as well as this page for updates.