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. We recommend you upload your proof of purchase, so you always have it in case you need it. All rights reserved. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Flurry will not associate your IP address with any other data held by Flurry. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. We understand that any change to your therapy device can feel significant. This recall was announced on June 14, 2021. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. 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. 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. Philips Respironics Sleep Apnea Care Questions about next steps after you have transferred your prescription settings? 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. Your IP address is anonymized prior to use and storage within Apptentive's products and services. 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. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. 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. FAQ 1. For further information about the Company's collection and use of personal information, please click the URL below. Proof of purchase is a printed receipt from the shopwhere you purchased your product, or a PDF invoice from an online retailer. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. 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. You can create one here. We know how important it is to feel confident that your therapy device is safe to use. You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. You can refuse to provide the Authorization for Collection and Use of Sensitive Information. Philips CPAP and BiLevel PAP Recall - VHA National Center for Patient You can sign up here. Please review the DreamStation 2 Setup and Use video for help on getting started. After registration, we will notify you with additonal information as it becomes available. Begin registration process 3163 1432 1800-28-63-020 9am-6pm (Mon-Fri) Select your mask type and specific mask model. 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. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. Enter your Username and affected Device Serial number. You are about to visit the Philips USA website. The advocacy demonstrated by the AASM has not been confirmed as a solution from CMS, however, so the best course of action is to call your Medicare or Medicaid provider directly regarding new sleep studies, reimbursement for repair costs, or the issuance of a new device. At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. 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. 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. You can still register your device on DreamMapper to view your therapy data. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Dont have one? 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. This is a potential risk to health. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. We encourage you to read it if youre experiencing hardship during this recall. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. 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.. The Company may provide a part or all of your personal information to a third party to facilitate the work. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. 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. Then you can register your product. Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. If you do not have a second device available we suggest you print out the instructions. December 2022 update on completed testing for first-generation DreamStation devices . 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. Fill out the registration form (leave Mobile Phone blank). Selected products If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. 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). How it works 1. Optional items: Email address and mobile phone number Philips issues Dreamstation CPAP recall notification | AASM This is a realistic look at what you can expect when removing the Foam from your recalled Philips DreamStation 1. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. We will continue daily checks with the Philips Respironics team to ensure we are executing everything possible to help our customers through this recall. As a result, testing and assessments have been carried out. Create New Account Fill out the registration form. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Click Save. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Using alternative treatments for sleep apnea. Here is the American Association of Sleep Medicines guidance to sleep physicians and their guidance to patients regarding the recall. Learn more about the full recall process here. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. Respironics CPAP Recall - Jotform Give us a call today and one of our 5 star customer service representatives will help you. We recommend you upload your proof of purchase, so you always have it in case you need it. Doing this could affect the prescribed therapy and may void the warranty. Can I have it repaired? This is a potential risk to health. (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP device.). 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. To register a product you need: MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. 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 do not have a second device available we suggest you print out the instructions. 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 Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. To improve our service quality and deliver up-to-date information and newsletters (text/email) You can register here. COPYRIGHT 19992021 US EXPEDITERS, INC. ALL RIGHTS RESERVED. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. 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. The issue is with the foam in the device that is used to reduce sound and vibration. 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. Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. Under normal circumstances, most private insurance companies replace your CPAP machine if youve had it for five or more years. On behalf of Philips, Flurry will use this information for the evaluation of your use of the App, compiling reports on App activity for Philips, and in order to provide other services relating to App activity and use of the App to Philips. Not all direct-to-consumer brands offer sales and discounts, though. 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. Duration of Retention and Use of Sensitive Information For patients using life-sustaining mechanical ventilator devices, they should not stop or change ventilator use until they have talked to their health care providers regarding factors including: 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. If your prescription has expired, its worth considering a home sleep testwhich lets you complete a sleep study from the comfort of your own bedto renew your prescription. Select country / language; Breathe easier, sleep more naturally . The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). 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. Enter the captcha characters. 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. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Items of Sensitive Information to be Collected By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Please review the attached. We may also send messages based on the date you set up your account. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. 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. Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. 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. In many cases when a product doesnt perform as you would expect, the problem can be resolved at home through basic troubleshooting. 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. Items of Personal Information to be Collected In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Click Submit to create your account. Philips Respironics DreamStation Auto SV - 1800CPAP 1. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. If you do not remember your DreamMapper password or need to reset it: Click Forgot Password?. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. 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. Buying a CPAP machine outright offers several advantages and can be the most cost-effective option. 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. 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. View/download instructions for desktop and laptop, Using an existing account on a desktop or laptop. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. Create a new password following the password guidelines. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You can find the list of products that are not affected. If you do not remember your DreamMapper password or need to reset it: Bluetooth pairing and data transfer Once you have successfully logged in, please select your mobile device operating system below for specific instructions on how to transfer the data from your current device to DreamMapper. We strongly recommend that customers and patients do not use ozone-related cleaning products. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. Optional item: Mobile phone number As a first step, if your device is affected, please start the. 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. Register your product and enjoy the benefits. 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