What Happened?
On June 14, 2021, Philips announced a voluntary recall notification due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in their CPAP and BiPAP machines*.
- Sound abatement foam may degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user, and
- the sound abatement foam may off-gas certain chemicals.
The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone sanitizing equipment, and certain environmental conditions involving high humidity and temperature. View Philips Official Recall Notification HERE and register your device if you have not done so. Philips recall toll-free number: 877-907-7508.
Latest update:
On 8/2/2022, Philips has been asked by the FDA (Federal drug administration) to set your replacement CPAP for your recalled device with your pressure settings BEFORE shipping to you directly. Only your Durable Medical Equipment Providers (DME) were able to provide your settings directly to Philips but ONLY until August 30th. Our form is now closed. See the most recent update above.
On 6/7/2022, Philips keeps working on the device remediation. Priority goes to the devices with data synchronized to Philips - FDA does not allow Philips to ship machines with default settings. The patients have to receive the machines with their previous machine settings and be ready to use. In order to do that, Philips used data sent through CPAP machines with remote connection functions via cellular or WiFi. These machines will be serviced quickly. If your machine does not have a wireless connection, or your machine has hardware but your machine seller did not open an account at careorchestrator.com for you, you may wait a bit longer.
However, you can still do something to prioritize your machine service. Check out our YouTube channel "Get Your Recall Prioritized".
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On 4/16/2022, Philips informed us that they have repaired/replaced almost 840k units out of 2.8 million registered units in the US and Canada last week. Philips is processing about 33k units each week. They will start selling the DreamStation 2 again when they are close to fulfilling all the registered requests.
On 3/23/2022, Philips added a patient portal where you can check your device status here:
Philips is asking customers at this time to inform them if they need Prioritization due to an underlying medical condition to receive their replacement more quickly. To do this you should go here and be prepared to enter your Philips registration confirmation number or serial number. You will also need to confirm your identity using your last name, zip code, and the last 4 digits of the phone number you used to register. If you are one of our international customers you will use our Zip Code 98052 and the last 4 digits of our phone number 3754 then on the next screen click the button "Add Prioritization".
On 12/07/2021, Philips confirmed that they are performing the repairs/replacements for the affected recalled CPAPs. The replacement/repair is expected to take until mid-2022. Patients will receive packages with a DreamStation 2, a new DreamStation with the new approved sound abatement foam, or a refurbished DreamStation with the new foam. We do not know who will receive what or when. Please follow the instructions in the packages to return the recalled machines. Keep all accessories including filters, bags, modems, power adapters, and humidifiers. You will receive a label to return your affected blower with your replacement in most cases.
On 10/19/2021, Philips is focusing on replacing some of the affected DreamStations with the new DreamStation 2, as Philips has them in stock. Many of our patients received the replacements already. We believe the units used with ozone had a higher priority in the process. The repair has not started.
On 9/27/2021, Philips confirmed they are still waiting for FDA clearance, probably a 510(k) approval, on the new design. The approval at the beginning of this month was for the new foam design, but in order to service the impacted units, it seems FDA needs a holistic review and approval process (we don't have details). No old units are being re-managed or re-manufactured now (due to legal reasons, the process cannot be called "repaired"). Some patients are getting new DreamStation 2 replacement machines but they are only a small portion of the entire community. How lucky they are!
On 9/1/2021, Philips announced their new sound abatement foam has been approved by FDA. Philips is now moving forward to manufacturing the new foams and preparing for the actual replacement/repair process. We were told they will kick off in a few weeks (hope it is sooner).
On 8/26/2021, Philips confirmed they started replacements for some high-risk patients using DreamStation 2 CPAPs (which are using a different foam design and thus not impacted by recall). Philips uses some patient data like whether used ozone, or whether patients are pilots. The data could come from patient registration, Philips remote assistance website Careorchastrator, or other channels. Good move Philips!
On 8/23/2021, Philips predicts it takes approximately 12 months to complete the recall worldwide. Although the repairs/replacements are on hold until FDA approves their new foam design, Philips is making 55,000 repair kit per week in Q3 2021, and aim to 80,000 per week in Q4 2021. Once FDA gives the green light, Philips can start repair/replacement asap.
8/17/2021: Philips is sending (probably) 20,000-30,000 registered USPS mails to impacted customers if the original medical store purchased the machines from Philips and decided to let Philips notify patients that their units are under recall. The mails are not to initiate the repair or replacement process. All the information in the mail can be found on Philips's official website. Please pay attention to your USPS mailbox (not email!). Note: if you purchased machines from RespShop you won't receive these USPS mails as we chose to notify our patients via emails which is a much faster way.
8/17/2021, Philips is still waiting for FDA's approval for the new foam. Philips has tripled their production power of this new foam and is waiting for a green light from the FDA. Philips has not given us the replacement schedule yet. We don't have any information on which machines will be replaced and which ones will be repaired.
We 100% agree with our customers that the current delay we are experiencing in a resolution from Philips is unacceptable. We have a whole staff devoted to working with Philips every day for updates for our customers and pushing them to do the right thing. We will keep you informed if there are any further updates on the status of your machine replacement or repair.
Talk to Your Physician and Register Your Device For The Recall
1. Talk to your physician first.
Work with your physician to determine the most appropriate options for your treatment. It may be dangerous to stop using a CPAP machine, depending on your health conditions.
2. Register your machine (read the Q&A section below to locate your machine SN)
We are here for you. RespShop values our customers, and we are very proud of our after-sell customer services. Please complete the registration form below (regardless of where you purchased your CPAP device). All the information will be passed to Philips and they will notify you when you can start the repair or replacement procedures.
Note: Philips US only services patients living in the United States. If you acquired your device in the US but currently live out of the US, you can still register at the page above, RespShop will coordinate the repair or replacement procedure. You will need to ship the affected device to RespShop and RespShop will forward it to Philips for service. The serviced machine will be sent to RespShop and then forwarded to your international addresses. You will be responsible for international shipping costs. If you purchased your machine in another country, you need to contact your local Philips dealer.
Note: you don't have to be a RespShop customer for our recall service. Just sign up above and we will help with registration and information updates FREE of charge.
RespShop, a Philips official distributor, is assisting all US sleep apnea patients and Philips to collect information for the recall. Information submitted will be sent to Philips or its authorized company for recall purposes.
Keep Yourself In The Loop
Philips is still in the process of mapping out its repair/replacement regulations, this effort includes wide-scale, global ramping up of manufacturing, repair, services, and other functions to support the correction. We will keep you updated with email notifications.
Register at Philips
Register your recalled unit at Philips' site
- Register by yourself and follow up with the recall updates daily at their website.
RespShop Can Help
Resolutions
- Register your machine and Philips will notify you of the repair/replacement procedure
- Try RespShop's CPAP Rental Machine Program.
- Purchase a new machine. We may see a CPAP machine shortage in the next few months due to 1) Philips production moving to help resolve recalls; 2) COVID logistics impact.
Products Affected and Sold by RespShop
DreamStation ASV
DreamStation ST, AVAPS
DreamStation CPAP, Auto CPAP, BiPAP
DreamStation GO CPAP, APAP
SystemOne Q Series, and ASV4
REMStar SE Auto CPAP
Read Full CPAP Recall Models Here
Common Q&A
What's the official site for the recall?
How often does the issue occur?
Philips claimed 3 out of 10,000 machines, or 0.03%. To date, Philips has not received reports of patient impact or serious harm as a result of this issue.
How do I know whether my device is on the list?
Download the Philips recalled device model number list. If first a few letters/numbers of your device model number (which is located at the bottom of the machine) can be found, your device is in the recall list. If you cannot find the model number, contact RespShop sales@respshop.com, please.
Where can I locate the machine serial numbers?
Check the samples here: DreamStation. DreamStation Go, C Series, A Series BiPAP, 60 Series, 50 Series, Dorma SE.
Be mindful of zero and O (oh). Don't key in any space.
Do I have to register my device to get replaced or repaired?
Many impacted devices are very old and out of service life, Philips needs confirmation from the patients or DMEs before they take action to these units.
There are two registration channels: register by patients themselves or ask the store you purchased the devices to register for you.
I have a machine on the recall list. Who should I contact?
Contact your physicians first. They will be able to tell whether using the device will bring more harm or whether you should keep using it while you are waiting for the recall service.
Device registration: patients can register at https://www.philipssrcupdate.expertinquiry.com/. The site will ask for your device serial number, and contact info and will follow up for the recall. You can also ask the original CPAP seller to register the machines for you.
We strongly encourage you to subscribe (see above) to our recall mailing list for the latest updates.
Do I have to ship the unit to the CPAP seller for recall service, or shipped to Philips directly? I do not want the package to be rerouted and thus delay my therapy.
It depends. Some DMEs with local storefronts may choose to service the machines for their patients so patients need to go through them. Most other CPAP stores (RespShop is one of them) chose to let Philips handles all the replacements or repair. Ask your original CPAP seller which route they decided on.
If your CPAP seller decided to let Philips handle the recall, Philips will email you the call tag with the FedEx/UPS labels for return service when return/repair starts. The service units will be shipped to you from Philips directly.
Philips will not handle ventilation and higher-end level BiPAP devices so they have to go through RespShop. These devices included DreamStation AVAPS/ST, 50/60/DreamStation ASV, C series AVAPS/ST, etc.
Are affected devices being replaced or repaired?
According to Philips, they may use the following policies for remediation (not the final version):
| Device Type | New Device | Refurbished | DreamStation 2 | Repair |
| DreamStation CPAP and BiPAP Pro/Auto |
Y | Y | Y | Y |
| SystemOne (Q-Series), REMstar SE Auto |
Y | Y | ||
| DreamStation Go | Y | Y | ||
| DreamStation ASV, ST, AVAPs | Y | Y | Y | |
| C-Series ASV, C-Series S/T, AVAPS, SystemOne ASV4 |
Y | |||
| Trilogy 100/200 | Y | |||
| V30 | Y | |||
| E30 | Y | Y |
Will the replacement/repair be free?
Yes.
Is the shipping free?
All US shipping is free. If you currently live outside of the US, you will be responsible for the round-trip international shipping cost to/from RespShop office in Redmond, WA.
My machine is very old, eg, 50 series and PR system one. Any suggestions?
We suggest you purchase a brand new machine asap. CPAP machines usually last for 5 years. Even without the recall, the machine motor may be worn, not be able to provide sufficient and accurate pressures, and may be noisy. There may be dust accumulating inside the machine. Read our blog article: 3 Signs Your CPAP is About to Kick the Bucket.
RespShop expected there will be a CPAP machine shortage in the US market for a few months. If you decide to buy a new one, buy it asap.
Are any other products affected, like masks or oxygen concentrators?
No.
Is the humidifier recalled?
No. Only the blower (aka CPAP machine itself) is recalled.
Are affected devices safe for use? Should affected devices be removed from service?
The recall notification advises customers using Bi-PAP and CPAP devices: to discontinue the use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. Philips is recommending that customers and patients halt the use of ozone-related cleaning products, and adhere to their device Instructions for Use of approved cleaning methods.
When will the correction for this issue begin? How long will it take to address all affected devices?
On 12/07/2021, Philips confirmed the repair/replacement is underway. They expected the entire recall will be done by summer 2022.
Will Philips provide a backup machine while my machine is being serviced?
No.
If my machine is to be replaced, will Philips ship the new machine to me before I ship the impacted device back?
Philips will ship you a replacement first, and you return the recalled machine, so there won't be a gap.
Is using ozone cleaning still safe or recommended?
We suggest using ozone cleaning only for CPAP masks or parts. Do not use the ozone to clean any electrical equipment.
What If my machine was purchased in another country?
Contact your local Philips or Philips dealer. They will be able to help. Philips US won't service the international models.
I purchased my machine in the US but I live outside of the US now.
We suggest you contact your local Philips first. Philips in different regions may have different policies. If they can not help, you will need to mail the machine back to the US for repair or replacement.
When the service in the US starts, RespShop will offer complimentary services for US machines abroad. Stay tuned.
Are other manufacturer devices affected?
Only some Philips (Philips Respironics) models are affected. ResMed has its FAQ here.
