Create a new password following the password guidelines. 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. Purpose of Collection and Use of Personal Information Create New Account Fill out the registration form. The Company may provide a part or all of your personal information to a third party to facilitate the work. 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. Philips Respironics will continue with the remediation program. 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. Agree To register your device and check if your machine is included in the recall: Locate the serial number of your device. You are about to visit a Philips global content page. Philips Sleep and respiratory care. 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 contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. You can still register your device on DreamMapper to view your therapy data. 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. Create account Create an account Already have an account? If you continue using your device, please note that ozone is referenced by Philips Respironics as a potential contributing factor to degraded foam. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Further testing and analysis is ongoing. Then you can register your product. Duration of Retention 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). IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. Per the Philips Respironics recall notice: We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. Register your device (s) on Philips' recall website . Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. 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. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP device.). 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. 2. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Below youll find a list of commonly asked questions about the CPAP recall. 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. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. 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. What is the safety issue with the device? Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. To register your product, you'll need to log into you're my Philips 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. Further testing and analysis is ongoing. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. 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. 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 . By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. 2. How are you removing the old foam safely? Optional items: Email address and mobile phone number This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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). 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. 6. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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. How can I register my product for an extended warranty? Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. The issue is with the foam in the device that is used to reduce sound and vibration. You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. 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 . Philips Respironics will continue with the remediation program. Countries where the receiving parties are located:Japan, Europe, etc. Create a new password following the password guidelines. If you are considering purchasing a new machine to replace your Philips Respironics device, you must have a current prescription. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. I O We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. Can I have it repaired? 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. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. We thank you for your patience as we work to restore your trust. Purpose of Collection and Use of Personal Information In many cases when a product doesnt perform as you would expect, the problem can be resolved at home through basic troubleshooting. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. We encourage you to read it if youre experiencing hardship during this recall. Last year the FDA issued a safety communication about PAP cleaners. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 2. 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. 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.. Please review the DreamStation 2 Setup and Use video for help on getting started. 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. 2. This is a potential risk to health. Questions about registering, signing in or need any otherDreamMapper support? 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. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. is designed . 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. Dont have one? Connected. This App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. 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. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. All rights reserved. You are about to visit a Philips global content page. You can refuse to provide the Authorization for Collection and Use of Personal Information. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. We created this helpful guide to finding a low-cost CPAP machine if you cant afford to purchase a new machine. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. If the product does not perform after following the FAQs & troubleshooting steps. Give us a call today and one of our 5 star customer service representatives will help you. 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. 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). Philips Respironics Chief Executive Frans van Houten said, Were going to put all our capacity to focus entirely on replacing and repairing these units, a process he said would likely take a year. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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 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. This could affect the prescribed therapy and may void the warranty. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. 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. 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. 1. 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.