Important Recall from Philips Respironics

Philips Respironics has issued a voluntary recall notice for the Dreamstation 1, SystemOne and Remstar CPAP devices

On June 14th 2021, Philips Respironics issued a global recall notification for some of its CPAPs, BilLevel PAPs and ventilators “out of an abundance of caution” due to possible health risks associated with sound-proofing foam in the machines. Rest assured that Philips has issued this recall voluntarily, and the complaint rate for affected devices is only 0.03%.

At Apnea Health, every effort is being made to find ways to assist and support you. Your health is our number one priority. We’re monitoring the situation very closely, and updating our customers via this blog, our newsletter, Facebook Live videos and by snail mail.

By registering your device on Philips’ recall website, you’ll be given priority in any actions Philips takes and you’ll be provided with all the necessary information.

What you need to know about this recall and how you might be impacted:

What happened?
We’re here to help
What devices are affected?
What devices are NOT affected?
How to determine if your device is recalled?
Will the devices be repaired or replaced? How long will it take?
What is the international respiratory medical community advising for patients?
What’s Apnea Health is doing about the recall?
Global shortage of CPAP
Can I buy or rent a CPAP presently?
Register for stock availability and receive a quote
Watch our Facebook Live videos on the recall

What happened?

On June 14th 2021, Philips Respironics issued a global recall for some of its CPAP and BPAP devices “out of an abundance of caution” due to possible health risks associated with sound-proofing foam in the machines. Although there’s a low complaint rate (0.03% in 2020), Philips is initiating a voluntary recall to ensure patient safety.

The recall is associated with foam that’s used to make the devices quieter. According to Philips, the foam “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” that may be toxic and can irritate airways, cause headaches and possibly carry cancer risks.

They also say the foam degradation may be exacerbated by the use of ozone cleaners, and high heat and high humidity environments.

See news release

What devices are affected?

Machine Type: CPAP + BPAP

Machine Series:

SystemOne (Q-Series)
DreamStation
DreamStation Go
REMstar SE Auto

Please note the recently launched DreamStation 2 is not affected by the issue.

What devices are NOT affected?

This recall does NOT affect the DreamStation 2, Resmed AirSense 10 or the Fisher & Paykel SleepStyle.

Apnea Health is aware that some patients will want to replace their Philips device with another manufacturer’s device rather than wait for Philips’ replacement or repair procedure to be implemented.

Please note that delays are to be expected, given that some of the replacement devices are currently out of stock. You can pre-order our low-cost CPAP options in our online boutique or you can register to receive a notification when your item is restocked.

Machine Type: CPAP + BPAP

Machine Series:

Airsense 10 (for Him and for Her)
DreamStation 2
SleepStyle

How to determine if your device is recalled

Using your device’s serial number, you can verify if your device is affected and then register your machine to be repaired or replaced. By registering with Philips, you’ll receive information directly from the manufacturer at the same time we do.

You can find the serial number on the bottom or the back of your machine depending on the model you have.

Will the devices be repaired or replaced? How long will it take?

Presently, Philips hasn’t indicated if the CPAP will be refurbished by replacing the sound dampening foam or if they’ll replace the machine altogether. Our Philips representative believes DreamStation Pro devices will be replaced, while older CPAP models will probably be refurbished. Philips plans to address all affected devices as quickly as possible, but because of the number of affected units worldwide, it’s likely to take at least a year.

At Apnea Health, we’re providing Philips with all the information they need to replace our patients’ CPAPs, but we strongly recommend that you also register your device directly with Philips to hasten a resolution.

What’s the advice for patients?

The relevant medical associations for respiratory diseases, along with health authorities around the world, recommend continuing treatment and consulting your physician.

While waiting to speak with your sleep specialist, we encourage you to consult the recommendations of the American Thoracic Society (ATS):

For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant pulmonary, cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that they not stop their prescribed therapy until first discussing with their physician.

Do not panic! If you’re using a DreamStation and you haven’t been consistently cleaning it with an ozone cleaner, the problematic foam in your device will not have degraded and therefore, the risk of skin irritation, eye irritation, headaches and asthma is very low.

If you have an alternative CPAP, by all means use it. If you find bits of black foam in your hose, water chamber or mask, we recommend you stop using your Philips Respironics device immediately.

What’s Apnea Health doing about this recall?

Since hearing the news, we’ve been in daily communication with Philips Respironics to understand what aid we can provide our patients.

We’ve completed all steps currently available with Philips to help our patients move forward in the process.

We’re standing by, ready to help Philips Respironics technologically or logistically to speed getting help to our customers. As new information and options become available, we’ll adapt our operations accordingly.

We’ve notified all our customers affected by the recall through email, newsletter, and on social media. Those we can’t reach by digital means will receive a snail mail notice.

Each day, more information becomes available. We’ll continue daily checks with the Philips Respironics team to ensure we’re doing everything possible to help our customers through this recall.

As we learn more, we’ll update our customers via email, and inform the CPAP community at large using this blog.

Global CPAP shortage

With the recent recall of Respironics units, the CPAP world has temporarily lost a major CPAP supplier. The DreamStation is no longer being produced, and the new DreamStation 2 is already set to pre-order due to demand.

This has put a lot of pressure on CPAP manufacturers like Resmed and Fisher & Paykel. These competitors are having trouble meeting demand for CPAP machines and they’ve stopped accepting new orders. Consequently, across North America, we are experiencing a CPAP shortage without a definite end.

Even so, we want to let you know that we still have stock of our most popular machines, including the AirSense 10, the AirMini Travel CPAP and the SleepStyle from F&P, and we’re reserving these CPAPs for our in-clinic patients in Greater Montreal.

Please note that CPAP masks, accessories and replacement parts have NOT been affected by the CPAP shortage.

Can I buy or rent a CPAP presently?

Rentals? No, unfortunately, because of the CPAP shortage, CPAP rentals and trials are limited to patients referred to us by our sleep specialists.

Purchase in-clinic? Yes, we still have stock of the AirSense 10, the AirMini Travel CPAP and the SleepStyle from Fisher & Paykel; however, quantities are limited and they’re reserved for patients who make an appointment at one of our 9 clinics in Greater Montreal.

Purchase in our online boutique? No, with the current CPAP shortages, it’s not possible. You can however register to be notified when stock becomes available, or you can pre-order your machine.

CPAP masks and accessories and replacement parts have NOT been affected by the CPAP shortage.