Philips' CPAP Recall Updates as of 8/2/2022
1. Sound abatement foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and
2. 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.
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 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.
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.
- Register by yourself and follow up with the recall updates daily at their website.
Be mindful of zero and O (oh). Don't key in any space.
There are two registration channels: register by patients themselves or ask the store you purchased the devices to register for you.
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.
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.
|Device Type||New Device||Refurbished||DreamStation 2||Repair|
and BiPAP Pro/Auto
|SystemOne (Q-Series), REMstar
|DreamStation ASV, ST, AVAPs||Y||Y||Y|
|C-Series ASV, C-Series S/T,
AVAPS, SystemOne ASV4
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.
When the service in the US starts, Respshop will offer complimentary services for US machines abroad. Stay tuned.
* Your first month's charge includes the $59 one-time setup fee + the first month's rental fee. The setup fee is required for us to carefully sanitize the device, and replace brand-new filters, CPAP tubing, and humidifier water tub for you.
* There is a 10-day grace period added before we charge you the second month's rental fee to remedy transit time.
* CPAP Mask is not included in the rental program. Purchase your own mask here.