All oxygen concentrators, respiratory drug delivery products, airway clearance products. Select your mask type and specific mask model. Register your device on the Philips recall website or call 1-877-907-7508. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. You can still register your device on DreamMapper to view your therapy data. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Below youll find a list of commonly asked questions about the CPAP recall. Are there any recall updates regarding patient safety? Optional items: Email address and mobile phone number (, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. To register your product, you'll need to log into your MyPhilips account. You can find the list of products that are not affected. Purpose of Collection and Use of Personal Information 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. Koninklijke Philips N.V., 2004 - 2023. 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. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved First Night Guide. However, this recall is not a normal circumstance and different insurance companies will have varying courses of action for you to follow. 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. Note: Please use the same email address you used when registering your device for the voluntary recall. 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*. Advisory - Philips Respironics recalls several models of CPAP and Once the purpose of use is achieved, your sensitive information will be destroyed immediately, unless otherwise required by laws. 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? Dont have one? Enter your Username and affected Device Serial number. You are about to visit the Philips USA website. Respironics CPAP Recall - Jotform If you do not have a second device available we suggest you print out the instructions. Doing this could affect the prescribed therapy and may void the warranty. 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. Philips DreamStation 2 . The Dream Family offers innovative, comprehensive sleep therapy technology like: . 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. We thank you for your patience as we work to restore your trust. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. FAQ 1. Fill out the registration form (leave Mobile Phone blank). 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. Please visit mydreammapper.com by clicking the Login button above. The serial number is located on the bottom of your device and it begins with "P" or "J" and contains 13 characters or begins with "D" and contains 14 characters. Cant Afford a New CPAP Machine? Duration of Retention and Use of Personal Information Philips issues Dreamstation CPAP recall notification | AASM IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. If the product does not perform after following the FAQs & troubleshooting steps. 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. Philips CPAP Recall Lawsuit Update - 2022 Settlement Information Please know that your health and safety is our main priority, as we work through this process. As a first step, if your device is affected, please start the. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. To register your product, youll need to log into your MyPhilips account. Philips Sleep and respiratory care. Create a new password following the password guidelines. Purpose of Collection and Use of Sensitive Information is designed . 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? With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Success. 2. The Company may provide a part or all of your personal information to a third party to facilitate the work. 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. If you allow us to use this information for marketing purposes, we may send you marketing messages based on your device model. We strongly recommend that customers and patients do not use ozone-related cleaning products. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. If you are used to using a DreamStation CPAP device and have received a new DreamStation 2 CPAP Adanced, this new device has also been set to the same prescription settings as before and is ready for use. 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 . 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. Enter your Username and affected Device Serial number. We recommend you upload your proof of purchase, so you always have it in case you need it. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). Those who have Medicare are in a similar case-by-case situation. This is a potential risk to health. 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. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. Our experts know CPAP inside and out. We also offer frequent discounts on our machines, masks, and other CPAP accessories, which can help you save money on the equipment you need. You can still register your device on DreamMapper to view your therapy data. 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. What CPAP machines are on recall? Confirm the new password in the Confirm Password field. 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. Product Support: 541-598-3800. Intuitive. 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). 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. We stand by, ready to help Philips Respironics technologically or logistically if needed to quicken getting help to our customers. 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. Register your child's device on the recall website or call (877) 907-7508 for assistance. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. To register your product, youll need to log into your MyPhilips account. 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%). Product registration | Philips If you do not have a second device available we suggest you print out the instructions. We are happy to review your prescription if youre unsure of its status. To register your product, you'll need to log into you're my Philips account. There are currently no items in your shopping cart. The issue is with the foam in the device that is used to reduce sound and vibration. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. The information is being updated on a regular basis and answered based on the latest safety communications from the FDA. In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. You are about to visit a Philips global content page. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). You can sign up here. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. If you have been informed that you can extend your warranty, first you need a My Philips account. 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 . 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). When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. 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. 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. 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. Please note that it is important that you only use approved cleaning methods for our devices and masks, as unapproved cleaning methods such as ozone may contribute to foam degradation. Doing this could affect the prescribed therapy and may void the warranty. Philips Respironics You can still file a claim for reimbursement, but keep in mind that reimbursement is fully dependent on your insurance provider. Simplified. We recommend you upload your proof of purchase, so you always have it in case you need it. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Note: Please use the same email address you used when registering your device for the voluntary recall. 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. Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. This is a potential risk to health. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP device.). 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. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 6. If you do not have a second device available we suggest you print out the instructions. Here is the American Association of Sleep Medicines guidance to sleep physicians and their guidance to patients regarding the recall. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Register your device (s) on Philips' recall website . 2. Further testing and analysis is ongoing. 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. Dont have one? Mandatory items: Time of device use as per the patient's use, prescribed pressure, degree of mask leak, and periodic breathing rate This recall was announced on June 14, 2021. FDA Green Lights Repair and Replacement Program for 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. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 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. Items of Sensitive Information to be Collected This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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 View/download instructions for Android devices, View/download instructions for Apple devices, Using an existing account on your mobile device. Product registration | Philips Click Save. 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. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines 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 CPAP and BiLevel PAP Recall - VHA National Center for Patient We may also send messages based on the date you set up your account. Cancel. Pricing for CPAP, APAP, and BiPAP machines vary; the average cost of a CPAP machine ranges from $300 to $850, though those with advanced technology features can cost more. Dont have one? DreamMapper - Apps on Google Play You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer . 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. Information for Physicians and other medical care providers - Philips By design. 2. 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. You can log in or create one. The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). This process should take about 10 minutes to complete, but may vary based on internet speed or device used. All of the relationships we hold dear, our family, friends, coworkers, and customers are affected. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Click Register. The company announced that it will begin repairing devices this month and has already started . We will continue to provide regular updates to you through monthly emails. We thank you for your patience as we work to restore your trust. 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. To register your product, youll need to. 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. Countries where the receiving parties are located:Japan, Europe, etc. 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 . Have the product at hand when registering as you will need to provide the model number. Still, buying a new CPAP machine through insurance is the best option for some. Periodically, DreamMapper data is analyzed to determine where improvements can be made to the application and to determine the frequency that functions within the application is used. 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. As we learn more, we will update our customers via email and the CPAP community at large using this blog. Information for patients and caregivers | Philips Philips Respironics Mask Selector uses no-touch. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.. Register your product and enjoy the benefits. Not all direct-to-consumer brands offer sales and discounts, though. Then you can register your product. You can sign up here. Confirm the new password in the Confirm Password field. In compliance with Philips instructions and standard recall practices, CPAP.com is not replacing recalled products with current stock nor issuing refunds for past orders. Koninklijke Philips N.V., 2004 - 2023. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. You can sign up here. 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. Items of Personal Information to be Collected Method of provision:Electronically transfer immediately upon authorization for collection and use of personal information 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. Using a new account on a desktop or laptop. Selected products If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. All rights reserved. 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. Register your product and start enjoying benefits right away. 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. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto . Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. PDF URGENT: Medical Device Recall - Philips The recall effects millions of units and replacement isn't coming for a long. 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. 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. Philips Respironics CPAP Recall Registration Form - YouTube Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. 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. 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. 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. 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. If you do not have a second device available we suggest you print out the instructions. Philips provides update on completed set of test results for first 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. I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back, Philips Respironics Sleep and Respiratory Care devices, Information for patients, all in one place, Learn how to set-up and use your replacement device . On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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. Create a new password following the password guidelines. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. 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.