The information is being updated on a regular basis and answered based on the latest safety communications from the FDA. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 1. In that case, your use of the service provided in this application through collection of personal information may be restricted. Register your child's device on the recall website or call (877) 907-7508 for assistance. We created this helpful guide to finding a low-cost CPAP machine if you cant afford to purchase a new machine. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. 283% You can refuse to provide the Authorization for Collection and Use of Personal Information. on the latest safety communications from the FDA. 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. 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. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Purpose of Collection and Use of Sensitive Information Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Click Save. Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview 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 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. 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. If you allow us to use this information for marketing purposes, we may send you marketing messages based on your device model. Click Next. You can still file a claim for reimbursement, but keep in mind that reimbursement is fully dependent on your insurance provider. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. The website will give you instructions on how to locate the serial number of your device. You can create one here. Apologize for any inconvenience. You can sign up here. Log in We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. 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. To register a new purchase, please have the product on hand and log into your My Philips account. Philips DreamStation 2 . Philips Respironics has provided the relevant regulatory agencies with required information related to the launch and implementation of the projected correction and contracted with a third-party vendor to coordinate the recall effort. Click Next. How are you removing the old foam safely? If you do not have this letter, please call the number below. As information becomes available, we will update our customers via email and the CPAP community at large using this blog. Agree The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. This is a potential risk to health. Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. to help you and your patients succeedtogether. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. If you do not have a second device available we suggest you print out the instructions. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Register your product and enjoy the benefits. Mandatory items: Country, name, email address, and serial number of the device used Register your device (s) on Philips' recall website . We understand that any change to your therapy device can feel significant. Countries where the receiving parties are located:Japan, Europe, etc. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Please visit mydreammapper.com by clicking the Login button above. 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. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. It also will guide you through the registration process. 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 . The data shared includes your usage of the device, mask leak measurements, CPAP pressure and your periodic breathing rate. On behalf of Philips, Apptentive will use information about your device (such as manufacturer, model, and operating system), app usage patterns, and information you elect to provide (such as survey responses or feedback) to provide services to Philips to help them understand App usage, provide support, and improve their products and services. 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. Since solutions for the recall are almost as personalized as individual pressure settings themselves, its important to have a discussion with your doctor as soon as possible to determine the next steps. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. As new information and options become available to help our customers we will switch our operations accordingly. Flurry will not associate your IP address with any other data held by Flurry. Product Support: 541-598-3800. 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! Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Please know that your health and safety is our main priority, as we work through this process. COPYRIGHT 19992021 US EXPEDITERS, INC. ALL RIGHTS RESERVED. Success. 2. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. You are about to visit a Philips global content page. Create New Account Fill out the registration form. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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.. Enter your Username and affected Device Serial number. This is a potential risk to health. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. How can I register my product for an extended warranty? Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). The Dream Family offers innovative, comprehensive sleep therapy technology like: . You can still register your device on DreamMapper to view your therapy data. 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. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. 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. Register your product and start enjoying benefits right away. How it works. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. Access all your product information in one place (orders, subscriptions, etc. To register your product, youll need to log into your MyPhilips account. Optional items: Email address and mobile phone number Select your mask type and specific mask model. 1. You can log in or create one. Philips Respironics guidance for healthcare providers and patients remains unchanged. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. We agree. 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. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved A patient no longer needs to tap a Ramp button every night to start at the desired pressure. To register your product, youll need to log into your MyPhilips account. Then you can register your product. We recommend you upload your proof of purchase, so you always have it in case you need it. What is the advice for patients and customers? Dont have one? In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. 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. 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). Call1.800.356.5221M-F 8AM-8PM | Sa 8AM-5PM (CST). Koninklijke Philips N.V., 2004 - 2023. Philips Respironics continues to monitor recall awareness for affected patients [1]. As a result, testing and assessments have been carried out. My product is not working. 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. 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. 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. Select country / language; Breathe easier, sleep more naturally . 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 Company may provide a part or all of your personal information to a third party to facilitate the work. Last year the FDA issued a safety communication about PAP cleaners. What is the safety issue with the device? 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. 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. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). All rights reserved. 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 have been informed that you can extend your warranty, first you need a My Philips account. 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. If you do not have a second device available we suggest you print out the instructions. Philips Respironics Mask Selector uses no-touch. You can also upload your proof of purchase should you need it for any future service or repairs needs. As a first step, if your device is affected, please start the registration process here. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. 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. Have the product at hand when registering as you will need to provide the model number. 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. 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. 2. 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. 2. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. To register your product, you'll need to log into you're my Philips account. Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. Create a new password following the password guidelines. You can sign up here. 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. 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. Email: respironics.service10@philips.com. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. If the product does not perform after following the FAQs & troubleshooting steps. Enter your Username and affected Device Serial number. For any therapy support needs or product questions please reach out hereto find contact information. 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 Doing this could affect the prescribed therapy and may void the warranty. We recommend you upload your proof of purchase, so you always have it in case you need it. Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. Confirm the new password in the Confirm Password field. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. 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 foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Optional item: Mobile phone number To register a new purchase, please have the product at hand and log into your MyPhilips account. Have the product at hand when registering as you will need to provide the model number. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Below youll find a list of commonly asked questions about the CPAP recall. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. 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. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. Begin registration process 3163 1432 1800-28-63-020 9am-6pm (Mon-Fri) What devices have you already begun to repair/replace? Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Heres How to Get Low-Cost or Free CPAP Supplies! DreamStation 2 Auto CPAP Advanced. Confirm the new password in the Confirm Password field. If you do not have a second device available we suggest you print out the instructions. You are about to visit a Philips global content page. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. What CPAP machines are on recall? Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Koninklijke Philips N.V., 2004 - 2023. Per Philips Respironics, products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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.. This approach needs to go through some regulatory hurdles first. While Philips recommends patients to discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment, we understand that many are not satisfied with this answer. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. If you are a patient who has been affected by this recall, please do not try to remove the foam from your 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.