FAQ 1. Don't have one? 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. 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. Flurry Analytics uses cookies or similar techniques, which are text files placed in your App, in order to help the App to analyze overall traffic patterns through our App. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Login with your Username and new Password. Enter your Username and Password and click Login. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. 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? This is a realistic look at what you can expect when removing the Foam from your recalled Philips DreamStation 1. We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process. 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 . This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. If you do not have this letter, please call the number below. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to restore affected first-generation DreamStation devices by replacing the PE-PUR sound abatement foam with a new material. 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. If you are considering purchasing a new machine to replace your Philips Respironics device, you must have a current prescription. However, this recall is not a normal circumstance and different insurance companies will have varying courses of action for you to follow. If you continue using your device, please note that ozone is referenced by Philips Respironics as a potential contributing factor to degraded foam. You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. 2. As a first step, if your device is affected, please start the registration process here. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone.Product DescriptionThe Philips Respironics . You can sign up here. We thank you for your patience as we work to restore your trust. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary recall notification. 2. December 2022 update on completed testing for first-generation DreamStation devices . ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Amsterdam, the Netherlands - In June 2021, Royal Philips' (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and . You can find the list of products that are not affected here. 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 1. As a first step, if your device is affected, please start the. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can sign up here. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. 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. Our experts know CPAP inside and out. Auto CPAP Advanced. We know how important it is to feel confident that your therapy device is safe to use. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient Success. Enter the captcha characters. Click Register. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Confirm the new password in the Confirm Password field. 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. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Next As we learn more, we will update our customers via email and the CPAP community at large using this blog. Please click either Yes or No. 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. Philips Respironics Mask Selector uses no-touch. You can still register your device on DreamMapper to view your therapy data. Then you can register your product. 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. 2. Dont have one? Philips Sleep and respiratory care. First Night Guide. 1. This recall was announced on June 14, 2021. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. This could affect the prescribed therapy and may void the warranty. Product Support: 800-685-2999. In this video, we will be going into detail about the process to register your device on the Philips website. You can find the list of products that are not affected. 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. The CPAP team strives to provide insightful and meaningful information to its audience, keeping you in the know on the latest happenings in the sleep health and respiratory world. Despite sincere and full efforts by members of the Philips Respironics team weve been in contact with, details and actions we can take immediately to have a positive impact on the health of our customers have been in short supply. While the CPAP recall is a frustrating experience, it does serve as an opportunity to switch up your CPAP equipment set-up so you can find the device that serves your needs best. 283% By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. Many of the Philips Respironics CPAP, APAP, and BiPAP machines sold from 2009 onward except the DreamStation 2 used this type of sound abatement foam and are impacted by this recall. Click Save. The App uses Apptentive, a feedback and communication service ("Apptentive") provided by Apptentive Inc. Apptentive uses a technology similar to a "cookie" in order to help the App analyze overall traffic patterns and collect your feedback through the App. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Here is the American Association of Sleep Medicines guidance to sleep physicians and their guidance to patients regarding the recall. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Dont have one? 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. You can still register your device on DreamMapper to view your therapy data. The issue is with the foam in the device that is used to reduce sound and vibration. You should have received a letter from Philips about this issue that contains log-in credentials for the registration website. Per Philips Respironics, the issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. Philips has established a registration process where you can look up your device serial number and begin a claim if your . to help you and your patients succeedtogether. If the product does not perform after following the FAQs & troubleshooting steps. We recommend you upload your proof of purchase, so you always have it in case you need it. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). You are about to visit a Philips global content page. The website will give you instructions on how to locate the serial number of your device. Heres How to Get Low-Cost or Free CPAP Supplies! Using alternative treatments for sleep apnea. 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. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Optional items: Email address and mobile phone number Countries where the receiving parties are located:Japan, Europe, etc. Once the purpose of use is achieved, your sensitive information will be destroyed immediately, unless otherwise required by laws. I O You can log in or create one here. Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview COPYRIGHT 19992021 US EXPEDITERS, INC. ALL RIGHTS RESERVED. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. Mandatory items: Country, name, email address, and serial number of the device used It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. The company announced that it will begin repairing devices this month and has already started . The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. scanning technology for the right mask fit from the start. Then you can register your product. First Night Guide. Further testing and analysis is ongoing. If youre considering purchasing a machine outright and are a long-time user of the DreamStation, we encourage you to check out this article to see how the ResMed AirSense 10 stacks up against the currently-recalled DreamStation from Philips Respironics. We will continue to take any actions Philips Respironics or the organizations governing them approve relating to this recall as quickly as we are able to execute them. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Duration of Retention and Use of Personal Information In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. To register your product, youll need to log in to your My Philips account. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. For further information about the Company's collection and use of personal information, please click the URL below. Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. 2. We recommend you upload your proof of purchase, so you always have it in case you need it. Using alternative treatments for sleep apnea. Agree Fill out the registration form (leave Mobile Phone blank). Last year the FDA issued a safety communication about PAP cleaners. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Click Save. Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. Do not Use, Next How it works 1. Note: If you are using a mask from another manufacturer, please select Mask Not Listed. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. All rights reserved. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary recall notification. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Don't have one? With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Per Philips Respironics, products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. 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. Purpose of Collection and Use of Sensitive Information In some cases, this foam showed signs of degradation (damage) and chemical emissions. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. The advocacy demonstrated by the AASM has not been confirmed as a solution from CMS, however, so the best course of action is to call your Medicare or Medicaid provider directly regarding new sleep studies, reimbursement for repair costs, or the issuance of a new device. Bluetooth pairing and data transfer 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Your individual coverage with Medicare or Medicaid will determine how to proceed with 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. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. 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. Register your product and start enjoying benefits right away. You are about to visit the Philips USA website. Enter the Captcha characters. Access all your product information in one place (orders, subscriptions, etc. Below is the information you need to know on this recall, how you might be impacted, what next steps should be taken, and what you should expect. Philips Respironics DreamStation 2 Auto CPAP Advanced with Humidifier BY Philips Respironics Item #DSX520H11C $1205.00 5 Reviews QTY 1 Out of Stock Prescription required Free Shipping Need replacement parts and accessories? If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. What is the safety issue with the device? Questions about registering, signing in or need any otherDreamMapper support? 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. Further testing and analysis is ongoing. Enter your Username and affected Device Serial number. 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. To register your product, youll need to log into your MyPhilips account. Apologize for any inconvenience. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. Dont have one? Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. 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. The company intends to complete its repair and replacement programs within approximately 12 months. Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer . You will be using Bluetooth to transfer your therapy results to the DreamMapper app. Flurry will not associate your IP address with any other data held by Flurry. Register the device on the recall website www.philips.com/src-updates The website provides current information on the status of the recall and how to receive permanent corrective action to. If you do not have a second device available we suggest you print out the instructions. Please review the DreamStation 2 Setup and Use video for help on getting started. Create a new password following the password guidelines. We also offer frequent discounts on our machines, masks, and other CPAP accessories, which can help you save money on the equipment you need. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. 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! Note: Please use the same email address you used when registering your device for the voluntary recall. In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. All rights reserved. You can change your settings any time if you prefer not to receive these communications. on the latest safety communications from the FDA. To register a new purchase, please have the product on hand and log into your My Philips account. You are about to visit the Philips USA website. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. You are about to visit a Philips global content page. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Philips Respironics will continue with the remediation program. 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. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. Dont have one? One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. 1. Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission Dear Device Customer, Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. 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. The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced. Please visit mydreammapper.com by clicking the Login button above. When you provide the Authorization for Collection and Use of Personal Information below, you can use services for improved enhance treatment adherence through this application. Register your device (s) on Philips' recall website . 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. The following products listed are affected by the recall notification / field safety notice: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Also known as BiPAP Hybrid A30Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. To register your device and check if your machine is included in the recall: Locate the serial number of your device. We thank you for your patience as we work to restore your trust. How can I register my product for an extended warranty? 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 . (, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Dreammapper has the ability to send you in app notifications based on inputs you provide directly when you set up your account, such as what mask you use, in addition to promotional messaging from Philips. 1. In that case, your use of the service provided in this application through collection of personal information may be restricted. View/download instructions for desktop and laptop, Using an existing account on a desktop or laptop. 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. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Connected. This is a potential risk to health. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. As part of the remediation process, customers and patients will be provided with more information on the next steps to implement the permanent solution as it becomes available. Items of Sensitive Information to be Collected Items of personal information provided: Country, name, email address, device serial number, and telephone number After youve registered your machine with Philips, you may be asking, what are my options for continuing therapy while I wait for Philips to send me a replacement machine or repair kit? You are about to visit a Philips global content page. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. Purpose of Collection and Use of Personal Information The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Please note that it is important that you only use approved cleaning methods for our devices and masks, as, We know how important it is to feel confident that your therapy device is safe to use. DreamStation Go: Whether you're traveling for business or venturing out on the vacation of a lifetime, DreamStation Go provides an easy, reliable and portable PAP experience for users who . 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. 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*. Questions about next steps after you have transferred your prescription settings? Cancel. All rights reserved. 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. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. It also will guide you through the registration process.
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