We will continue daily checks with the Philips Respironics team to ensure we are executing everything possible to help our customers through this recall. Philips DreamStation 2 . View/download instructions for Android devices, View/download instructions for Apple devices, Using an existing account on your mobile device. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Selected products Register your product and enjoy the benefits. For us to send you a replacement device, we will first need to get your prescription settings from your current device and then we will load those into your replacement device. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. For us to send you a replacement device, we will first need to get your prescription settings from your current device and then we will load those into your replacement device. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. The company announced that it will begin repairing devices this month and has already started . Each day more information becomes available. You can log in or create one here. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. Enter your Username and affected Device Serial number. You are about to visit a Philips global content page. We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs., Philips Respironics identified there is risk the PE-SUR sound abatement foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. Create New Account Fill out the registration form. This is a realistic look at what you can expect when removing the Foam from your recalled Philips DreamStation 1. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. In some cases, this foam showed signs of degradation (damage) and chemical emissions. We thank you for your patience as we work to restore your trust. September 02, 2021. Further testing and analysis is ongoing. All rights reserved. We understand the profound impact this recall has had on you, and that for those who are waiting for a repaired or replaced device, this progress cant come quickly enough. Philips Respironics is initiating its repair and replacement program in other countries and expects the program to be underway in most markets by the end of September 2021. Since the news broke, customers have let us know they are frustrated and concerned. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. We Asked A Sleep Doctor About The Recent CPAP RecallHeres What He Said, Ultimate How To Guide: Best Ways To Clean Your CPAP, A Complete Review of the Lumin CPAP Mask Cleaner in 2023, ResMed AirSense 10 CPAP Machine Review Updated 2023 Card-to-Cloud Model, A-Series BiPAP Hybrid A30 (not marketed in US). Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. This video shows how the patient (device user) can check if their Philips Sleep and Respiratory Care medical device is affected by the recall and if so, how . For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation All oxygen concentrators, respiratory drug delivery products, airway clearance products. Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include: The best way to know if your device is included in the recall is to register your machine for the recall. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. On Monday, June 14th, Philips Respironics issued a voluntary recall on nearly all of their CPAP, APAP, and BiPAP machines sold from 2009 until today, with some exceptions. When you provide the authorization for collection and use of personal information below, you will be informed of various information about recent news and events via text message or email. Purpose of Collection and Use of Personal Information Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Additionally, we remind both customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series), Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US), Also known as BiPAP V30 Auto Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. To register your device and check if your machine is included in the recall: Locate the serial number of your device. All of the relationships we hold dear, our family, friends, coworkers, and customers are affected. This is a potential risk to health. You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. Learn more about the full recall process here. To do this you will need to register for a DreamMapper account or sign into your existing account using either the DreamMapper app on your moble device or via the DreamMapper website on your desktop or laptop computer. Give us a call today and one of our 5 star customer service representatives will help you. I O Confirm the new password in the Confirm Password field. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. Below youll find a list of commonly asked questions about the CPAP recall. Our experts know CPAP inside and out. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. You can sign up here. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. 6. Connect your DreamStation Your DreamStation has built-in support for Bluetooth which will connect to your mobile device and transfer your therapy results. We recommend you upload your proof of purchase, so you always have it in case you need it. For more information about how DreamMapper processes your data click here. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). You are about to visit a Philips global content page. Register your product and enjoy the benefits. . 2. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Under normal circumstances, most private insurance companies replace your CPAP machine if youve had it for five or more years. Philips Respironics has provided the relevant regulatory agencies with required information related to the launch and implementation of the projected correction and contracted with a third-party vendor to coordinate the recall effort. You can still register your device on DreamMapper to view your therapy data. Dont have one? VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Items of Sensitive Information to be Collected Register your product and enjoy the benefits. We recently spoke with Dr. Daniel Barone, an Attending Neurologist at New York Presbyterian/Weill Cornell Medical Center, to address some of the questions you may have about the recall and the impact it has on your sleep apnea treatment. To improve our service quality and deliver up-to-date information and newsletters (text/email) Apologize for any inconvenience. Confirm the new password in the Confirm Password field. Not all details of this recall are known at this time. All rights reserved. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. You can sign up here. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam*. Last year the FDA issued a safety communication about PAP cleaners. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Flurry will not associate your IP address with any other data held by Flurry. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. 283% Philips reports that, "The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects." Philips reports that the foam-related complaint rate in 2020 was low (0.03%). Click Return to Login after successful password reset. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you had a CPAP machine before you got Medicare, you will need to check with Medicare to see if you qualify for certain requirements that will cover the cost of the replacement of your machine. Please review the attached. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. The company intends to complete its repair and replacement programs within approximately 12 months. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Click Register. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) If you do not remember your DreamMapper password or need to reset it: Bluetooth pairing and data transfer Once you have successfully logged in, please select your mobile device operating system below for specific instructions on how to transfer the data from your current device to DreamMapper. View/download instructions for desktop and laptop, Using an existing account on a desktop or laptop. This is not our choice or our preference. Begin SD data card transfer Once you have successfully logged in, please open the instructions below for specific instructions on how to transfer the data from your current device to DreamMapper. We strongly recommend that customers and patients do not use ozone-related cleaning products. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. We learned of this recall at the same time as our customers and have been in daily communication with Philips Respironics since that time. Acknowledge all consents. As a reminder, we recommend using a second device to read through the step-by-step instructions for an easier set up and transfer process. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Click Next. Philips Respironics will continue with the remediation program. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. Login with your Username and new Password. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. How can I register my product for an extended warranty? Philips Respironics issued a voluntary product recall for its breathing devices and ventilators due to sound abatement foam that has a potential to break down. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Items of Personal Information to be Collected This recall notification/field safety notice has not yet been classified by regulatory agencies. As a first step, if your device is affected, please start the registration process here. Philips Korea Corporation (hereinafter the "Company") values your personal information and complies with applicable laws and regulations for personal information protection, including the Personal Information Protection Act. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. The recall effects millions of units and replacement isn't coming for a long. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved The issue is with the foam in the device that is used to reduce sound and vibration. Create a new password following the password guidelines. Dont have one? Select country / language; Breathe easier, sleep more naturally . scanning technology for the right mask fit from the start. No matter what type of health insurance coverage you have, you should call your health insurance group soon to see which steps you need to take once youve registered your device and spoken with your doctor. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. Duration of Retention and Use of Sensitive Information You can refuse to provide the Authorization for Collection and Use of Sensitive Information. Duration of Retention and Use of Personal Information We are partnering with clinicians and business customers throughout this process to ensure were doing all we can to help you and your healthcare needs. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. In that case, your use of the service provided in this application through collection of personal information may be restricted. As a result, testing and assessments have been carried out. For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this recall, do not try to remove the foam from your device. To register your device and check if your machine is included in the recall: Philips Respironics plans to replace the current sound abatement foam with a new material that is not affected by this issue. For those who cannot currently afford new equipment but who have been encouraged to continue their sleep apnea treatment, weve included a few solutions at the end of this article that we hope can be beneficial to you. Countries where the receiving parties are located:Japan, Europe, etc. Plus, most insurance companies require you to rent your equipment for a certain period of time and many require compliance monitoring to protect their investment. Philips Respironics offers innovative products for sleep and home respiratory care as well as medical education and value-added programs to help you navigate a rapidly changing industry landscape, and in the interest of maximizing both clinical and business success. Once you have created your account, please select your mobile device operating system below for specific instructions on how to transfer the data from your current device to DreamMapper. We understand the profound impact this recall has had on you, and that for those who are waiting for a repaired or replaced device, this progress cant come quickly enough. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. You can log in or create one. Create a new password following the password guidelines. 2. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. Note: Please use the same email address you used when registering your device for the voluntary recall. Here is the American Association of Sleep Medicines guidance to sleep physicians and their guidance to patients regarding the recall. 2. If you are using a mobile device to transfer your data, we recommend using a second device to read through the step-by-step instructions for an easier set up and transfer process. DreamStation 2 Auto CPAP Advanced. Per Philips Respironics, products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Enter the Captcha characters. Based on the extensive testing and analysis that we have done over the past 18 months - working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. While Philips recommends patients to discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment, we understand that many are not satisfied with this answer. Your insurance company may: There are some insurance companies who require the use of a Philips-brand machine only, so you will need to speak with a representative of your insurance company directly to determine a solution for repairing or replacing your current device. Register your child's device on the recall website or call (877) 907-7508 for assistance. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. How it works. We agree. 2. Additionally, the AASM requests flexibility from CMS in allowing and covering the cost of replacing recalled devices during the five-year reasonable useful lifetime. The letter suggests DME suppliers should be allowed to repair or replace the recalled equipment without the need for a new clinical evaluation or sleep test; requests for patient alleviation from potential repair or replacement costs were suggested, as well. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. Still, buying a new CPAP machine through insurance is the best option for some. Access all your product information in one place (orders, subscriptions, etc. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. As we learn more, we will update our customers via email and the CPAP community at large using this blog. As a result, testing and assessments have been carried out. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. The website will give you instructions on how to locate the serial number of your device. U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit. Per Philips Respironics CEO Frans van Houten We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety.. You can still register your device on DreamMapper to view your therapy data. This could affect the prescribed therapy and may void the warranty. We have completed all steps with Philips Respironics currently available to help our customers move forward in the process. Don't have one? Click Save. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. To register your product, youll need to log into your MyPhilips account. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. As a first step, if your device is affected, please start the. How are you removing the old foam safely? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. Then you can register your product. Select your mask type and specific mask model. You can find the list of products that are not affected here. You can log in or create one here. Enter your Username and Password and click Login. DreamMapper v 2.31.0.3 Koninklijke Philips N.V., 2004-2023 All rights reserved. Please review the DreamStation 2 Setup and Use video for help on getting started. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. You can sign up here. Luna 2 CPAP Review: How Does It Compare to the DreamStation? Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Once Philips Respironics has confirmed payment details and your acceptance of the estimate our service department will complete the repair or service and return the device to the shipping address you provide on the "Request for Service" form. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Login with your Username and new Password. 5. Receiving party's purpose of use of personal information: Store the collected information To register your product, you'll need to log into your MyPhilips account. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Learn About Sleep Apnea and Treatment Options, The Latest CPAP Machine Reviews from Experts, Find the Best CPAP Mask for Your Lifestyle, Our Top Picks to Make CPAP Cleaning a Breeze, Were here to help! Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. Please know that your health and safety is our main priority, as we work through this process. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Philips Respironics Mask Selector uses no-touch. If you do not have this letter, please call the number below. For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit. 1. According to an CPAP machine FDA recall notice issued on June 30, 2021, the following Philips Respironics sleep apnea and breathing devices sold between 2009 and April 2021 may pose serious health risks: CPAP and BiPAP Device Recalls Non-Continuous ventilators: DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto Authorization for Disclosure of Personal Information to a Third Party, I agree for my personal data to be processed in the DreamMapper App for creating my account and user profile and to provide a view of usage of my therapy device (s) to assist me with complying with my sleep therapy goals. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. For further information about the Company's collection and use of personal information, please click the URL below. Latest Update Regarding Philips Effort To Repair and Replace DreamStation Devices: On September 1, 2021 Philips Respironics issued a statement informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.