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. As this is an official recall, Philips Respironics must adhere to the regulatory requirements of a recall and specify the steps dealers, such as CPAP.com, must follow to adhere to the recall. 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 . It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Confirm the new password in the Confirm Password field. Further testing and analysis is ongoing. Per Philips Respironics, products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Information for Philips Respironics DreamStation users, How to transfer prescription settings from youraffected device so Philips Respironics can begin to prepare your replacement device, Using a new account on your mobile device. 3. With focusing all capacity on the recall, Houten said that approach has a consequence that we will not be able to serve new customers, so theres going to be a shortage in the field.. Duration of Retention and Use of Sensitive Information SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. 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. Login with your Username and new Password. The Dream Family offers innovative, comprehensive sleep therapy technology like: . 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. COPYRIGHT 19992021 US EXPEDITERS, INC. ALL RIGHTS RESERVED. 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. Connected. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. You are about to visit a Philips global content page. Philips Respironics will continue with the remediation program. You are about to visit a Philips global content page. Further testing and analysis is ongoing. Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. This is not our choice or our preference. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. Selected products 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. 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. Register your product and start enjoying benefits right away. To register your product, youll need to log into your MyPhilips account. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview Countries where the receiving parties are located:Japan, Europe, etc. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. Select country / language; Breathe easier, sleep more naturally . Philips Respironics will continue with the remediation program. As we learn more, we will update our customers via email and the CPAP community at large using this blog. High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation. 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. 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 here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Simplified. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Those who have Medicare are in a similar case-by-case situation. Create a new password following the password guidelines. Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. Purpose of Collection and Use of Personal Information If you continue using your device, please note that ozone is referenced by Philips Respironics as a potential contributing factor to degraded foam. We may also send messages based on the date you set up your account. 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. 283% The recall effects millions of units and replacement isn't coming for a long. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. Click Register. You can log in or create one. By design. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. In this video, we will be going into detail about the process to register your device on the Philips website. 2. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to replace the PE-PUR sound abatement foam with a new material, and the company anticipates the rework to begin this month for affected first-generation DreamStation devices in the United States. to help you and your patients succeedtogether. In that case, your use of the service provided in this application through collection of personal information may be restricted. Product Support: 541-598-3800. 5. Access all your product information in one place (orders, subscriptions, etc. Click Save. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Dont have one? Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows: For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include: Using another similar device that is not part of the recall. Enter your Username and affected Device Serial number. Buying a CPAP machine outright offers several advantages and can be the most cost-effective option. If you do not have a second device available we suggest you print out the instructions. If you are considering purchasing a new machine to replace your Philips Respironics device, you must have a current prescription. What can I do with a My Philips account? 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. Access all your product information in one place (orders, subscriptions, etc. Cancel. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. You can still register your device on DreamMapper to view your therapy data. 1. 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. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. Mandatory items: Country, name, email address, and serial number of the device used Email: respironics.service10@philips.com. To register your product, youll need to log into your MyPhilips account. Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer . Amsterdam, the Netherlands - Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the comprehensive test and research program of its subsidiary Philips Respironics, following the voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical . Purpose of Collection and Use of Personal Information Register your product and enjoy the benefits. Philips Respironics DreamStation CPAP Machine: Two-years limited warranty DeVilbiss IntelliPAP Standard CPAP Machine: Five-year warranty Somnetics Transcend EZEX miniCPAP Machine: Three-year warranty Manufacturer warranties actually begin on the day you buy the CPAP machine from the manufacturer. Under normal circumstances, most private insurance companies replace your CPAP machine if youve had it for five or more years. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. To register your product, youll need to log into your MyPhilips account. FAQ 1. 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. 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. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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. 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. 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. Duration of Retention and Use of Personal Information 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. You are about to visit a Philips global content page. Flurry will not associate your IP address with any other data held by Flurry. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. First Night Guide. You can log in or create one here. You can register here. We thank you for your patience as we work to restore your trust. 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. Items of Personal Information to be Collected 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). You are about to visit the Philips USA website. 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. To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. Log in Confirm the new password in the Confirm Password field. Heres How to Get Low-Cost or Free CPAP Supplies! 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. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. This recall was announced on June 14, 2021. Using alternative treatments for sleep apnea. We understand that any change to your therapy device can feel significant. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. As a first step, if your device is affected, please start the. We understand that any change to your therapy device can feel significant. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 6. Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. My product is not working. 2. As information becomes available, we will update our customers via email and the CPAP community at large using this blog. Create a new password following the password guidelines. To register your product, youll need to. Please click either Yes or No. For further information about the Company's collection and use of personal information, please click the URL below. Questions about registering, signing in or need any otherDreamMapper support? Philips has established a registration process where you can look up your device serial number and begin a claim if your . Please review the DreamStation 2 Setup and Use video for help on getting started. You can still register your device on DreamMapper to view your therapy data. If you do not have a second device available we suggest you print out the instructions. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. To register your product, you'll need to log into your MyPhilips account. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. In some cases, this foam showed signs of degradation (damage) and chemical emissions. You can still file a claim for reimbursement, but keep in mind that reimbursement is fully dependent on your insurance provider. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. 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 Register - Philips Respironics DreamMapper Register Country* First Name Last Name Email Address* Confirm Email Address* Mobile Phone Primary Device Serial Number I understand and accept the Terms and Conditions. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. 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. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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. 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. As a first step, if your device is affected, please start the registration process here. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. 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. The information is being updated on a regular basis and answered based on the latest safety communications from the FDA. Please visit mydreammapper.com by clicking the Login button above. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Give us a call today and one of our 5 star customer service representatives will help you. We strongly recommend that customers and patients do not use ozone-related cleaning products.