Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. First Night Guide. IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. This could affect the prescribed therapy and may void the warranty. Confirm the new password in the Confirm Password field. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. We will continue daily checks with the Philips Respironics team to ensure we are executing everything possible to help our customers through this recall. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com) The company anticipates the rework to begin this month. 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 . Items of Personal Information to be Collected This recall notification/field safety notice has not yet been classified by regulatory agencies. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. Purpose of Collection and Use of Sensitive Information 2. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. The Company may provide a part or all of your personal information to a third party to facilitate the work. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. 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. This is a potential risk to health. Enter your Username and affected Device Serial number. You can refuse to provide the Authorization for Collection and Use of Personal Information. There are currently no items in your shopping cart. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. You can still register your device on DreamMapper to view your therapy data. 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. As a result, testing and assessments have been carried out. 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. 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.. Amsterdam, the Netherlands - Following the company update on April 26, 2021, Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified . on the latest safety communications from the FDA. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Heres a list of Philips CPAP recall model numbers: Skip to: How do I know if my device was recalled? section for steps to check your specific machine. If you do not have a second device available we suggest you print out the instructions. Login with your Username and new Password. 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. As a first step, if your device is affected, please start the registration process 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. Acknowledge all consents. 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. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Doing this could affect the prescribed therapy and may void the warranty. Please review the DreamStation 2 Setup and Use video for help on getting started. Confirm the new password in the Confirm Password field. Note: Please use the same email address you used when registering your device for the voluntary recall. As information becomes available, we will update our customers via email and the CPAP community at large using this blog. 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 . Register your product and enjoy the benefits. Confirm the new password in the Confirm Password field. 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 a new password following the password guidelines. In this video, we will be going into detail about the process to register your device on the Philips website. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Learn more about the full recall process here. CPAP.com does not and has never sold ozone-related cleaning products. Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. All rights reserved. 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 www.philips.com/ds2-replacement for more information. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP device.). Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Optional items: Email address and mobile phone number If you cant afford a new machine outright or are having issues with your insurance provider, rest assured that there are several options that exist to find low-cost or free CPAP equipment, including government assistance or charity donation programs. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. Below youll find a list of commonly asked questions about the CPAP recall. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. By transmitting the information generated by the cookie about the use of the App to Flurry, your setting ensures that IP address is anonymized before geo-localization and will be replaced by a generic IP address before storage. Success. We thank you for your patience as we work to restore your trust. 1. Per Philips Respironics, products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. In that case, we cannot deliver recent information and newsletters, which is available only through collection of personal information. 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. 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. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. 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. Philips Respironics will continue with the remediation program. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. All rights reserved. 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. We stand by, ready to help Philips Respironics technologically or logistically if needed to quicken getting help to our customers. This spreadsheet provides Medicare DME fee schedule information, by HCPCS code . As a result, testing and assessments have been carried out. DreamMapper is part of the Dream Family from Philips Respironics. Click Return to Login after successful password reset. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. 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). 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). Click Submit to create your account. Don't 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: Stopping use of an affected device Using another similar device that is not part of the recall Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. Buying a CPAP machine outright offers several advantages and can be the most cost-effective option. 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. 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. As new information and options become available to help our customers we will switch our operations accordingly. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly. Enter your Username and affected Device Serial number. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. Login with your Username and new Password. 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. You can still register your device on DreamMapper to view your therapy data. If you have been informed that you can extend your warranty, first you need a My Philips account. You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. 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. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. Auto CPAP Advanced. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. By design. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Enter your Username and Password and click Login. To register your product, youll need to log into your MyPhilips account. FDA Green Lights Repair and Replacement Program for Philips DreamStation Recall, How do I know if my device was recalled?, a process he said would likely take a year, helpful guide to finding a low-cost CPAP machine. Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution. 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*. 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%). We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Register your device on the Philips recall website or call 1-877-907-7508. This recall was announced on June 14, 2021. Please review the DreamStation 2 Setup and Use video for help on getting started. You can sign up here. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto . 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. Philips Respironics DreamStation AutoSVPlease Note: Philips has stated there are possible risks to users related to the sound abatement foam used in certain Philip's sleep devices currently in use. Enter your Username and Password and click Login. Register your product and start enjoying benefits right away. 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. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. This App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. 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. You can register here. Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. Apologize for any inconvenience. We understand that any change to your therapy device can feel significant. To register your product, youll need to log in to your My Philips account. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Luna 2 CPAP Review: How Does It Compare to the DreamStation? 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. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. For further information about the Company's collection and use of personal information, please click the URL below. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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? Philips Sleep and respiratory care. 1. To register your product, youll need to log into your MyPhilips account. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. You are about to visit the Philips USA website. Please visit mydreammapper.com by clicking the Login button above. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 2. Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer . The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. 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. is designed . As we learn more, we will update our customers via email and the CPAP community at large using this blog. Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. This is a potential risk to health. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. Plus, it usually isnt as complicated as purchasing a new device through insurance. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. Create New Account Fill out the registration form. 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. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. 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 .