August 5, 2021 — Philips Respironics has issued a voluntary recall affecting some of the CPAP devices they manufacture. CPAP machines are one of the most common and effective treatments for sleep apnea, and many people use them nightly to treat the condition.
“Philips reports that it has received a low complaint rate (0.03% in 2020), but the possible problems are serious enough for the U.S. Food & Drug Administration to identify this as a Class I recall, which is the most serious type of recall,” according to Dr. Anuj Chandra, chairman of the Advanced Center for Sleep Disorders. “This is significant enough that it must be addressed, and every patient who uses one of the recalled CPAP machines must be aware of it.”
Philips is responsible for correcting the issue, including the deployment of updated instructions for use and a repair and replacement program for affected devices, and will be contacting all patients with the recalled devices.
“Since the day we received notification of the recall, our staff has been working overtime to get our patients’ information to Philips Respironics, so they could get in the queue for corrective actions,” said Dr. Chandra. “But we strongly recommend that patients also go to the Philips recall website and register their information to speed up the process.”
Patients can register for the recall by visiting philips.com/src-update. This site also provides more information about the recall. Patients can also call Philips toll-free at 877-907-7508.
Advanced Center for Sleep Disorders is also reaching out to these patients to schedule time for them to talk to our providers about what they should do. Our patients with questions can call the Center at 423-648-8008.
What is being recalled?
• Philips Respironics DreamStation CPAP and Bi-level PAP (also called Bi-PAP) equipment, made before April 2021.
• Newer models made after April 2021 and called DreamStation 2 are not included.
Should patients stop using these devices?
Do not stop before talking to your physician if…
• You have severe sleep apnea
• You have severe breathing difficulties
• You were very sleepy during the daytime before treatment
• You have significant pulmonary, cardiovascular or neurologic comorbidity
• You work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators)
For other patients, you should stop now, and then talk to your physician.
What is the problem?
• Polyester-based polyurethane foam used for noise abatement may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.
• Particles — Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.
• Chemicals — The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions.
• The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation. Philips is recommending that patients halt the use of ozone-related cleaning products ad follow their device instructions for use for approved cleaning methods.
Should patients try to remove the foam?
No. The FDA recommends that patients do not remove the sound abatement foam, as it may impact device performance and possibly introduce foam debris into the device.