On June 22nd, the American Academy of Sleep Medicine (AASM) and several medical societies and patient advocacy organizations submitted a letter to durable medical equipment (DME) contractors requesting patient support from the Centers for Medicare and Medicaid Services (CMS) since many individuals will be unable to meet CMS adherence requirements before their device can be fixed or replaced. Please check our online troubleshooting and FAQs to find solutions for the most common issues, Kindly contact with our consumer support team by the following this link. 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. What is the advice for patients and customers? 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. Click Save. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. 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. The issue is with the foam in the device that is used to reduce sound and vibration. Dont have one? In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. Always follow manufacturer-recommended cleaning instructions. Philips Respironics guidance for healthcare providers and patients remains unchanged. What CPAP machines are on recall? Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Dont have one? 1. The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com)
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. 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. Give us a call today and one of our 5 star customer service representatives will help you. Using alternative treatments for sleep apnea. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Items of Sensitive Information to be Collected
Please click either Yes or No.
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. 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 . 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. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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. We will continue daily checks with the Philips Respironics team to ensure we are executing everything possible to help our customers through this recall. We strongly recommend that customers and patients do not use ozone-related cleaning products. Connect your DreamStation Your DreamStation has built-in support for Bluetooth which will connect to your mobile device and transfer your therapy results. All rights reserved. Those who have Medicare are in a similar case-by-case situation. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Register your product and enjoy the benefits. 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 . How can I register my product for an extended warranty? Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. Select your mask type and specific mask model. 2. We Asked A Sleep Doctor About The Recent CPAP RecallHeres What He Said, Ultimate How To Guide: Best Ways To Clean Your CPAP, A Complete Review of the Lumin CPAP Mask Cleaner in 2023, ResMed AirSense 10 CPAP Machine Review Updated 2023 Card-to-Cloud Model, A-Series BiPAP Hybrid A30 (not marketed in US). To register your product, you'll need to log into you're my Philips account. Click Return to Login after successful password reset. 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. 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 . For further information about the Company's collection and use of personal information, please click the URL below. After youve registered your machine with Philips and have scheduled an appointment with your sleep care physician to discuss a new treatment plan, you may be wondering if you should keep using your recalled machine and what options exist if you decide its time to purchase a new machine altogether. Click Next.
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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Confirm the new password in the Confirm Password field. Create New Account Fill out the registration form. Login with your Username and new Password. Purpose of Collection and Use of Sensitive Information
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. Patient setup and training. Please review the DreamStation 2 Setup and Use video for help on getting started. Why do I need to upload a proof of purchase? Confirm the new password in the Confirm Password field. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. 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. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Do not Use, Next
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. 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. 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. 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. The company announced that it will begin repairing devices this month and has already started . Doing this could affect the prescribed therapy and may void the warranty. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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 . 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. 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. 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. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. We thank you for your patience as we work to restore your trust. 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. Register your product and enjoy the benefits. 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 improve our service quality and deliver up-to-date information and newsletters (text/email)
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 . Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Then you can register your product. 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. Further testing and analysis is ongoing. 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. 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. All rights reserved. You can refuse to provide the Authorization for Collection and Use of Personal Information. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. 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. To register your product, you'll need to log into your MyPhilips account. Duration of Retention and Use of Sensitive Information
The data shared includes your usage of the device, mask leak measurements, CPAP pressure and your periodic breathing rate. All rights reserved. Enter your Username and affected Device Serial number. 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. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. We know how important it is to feel confident that your therapy device is safe to use. However, this recall is not a normal circumstance and different insurance companies will have varying courses of action for you to follow. 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. The information is being updated on a regular basis and answered based on the latest safety communications from the FDA. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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 . Begin SD data card transfer 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. Optional item: Mobile phone number
We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. If you have not done so already, please click here to begin the device registration process. As mentioned, receiving a new device through your insurance plan requires a new prescription from your physician with documentation stating that you are using and benefitting from your sleep apnea treatment. Please read carefully and fully understand all terms of "Service Agreement" and "Privacy Policy", including but not limited to: to provide you with services of your usage of the device, we need to collect personal information like information about your device,operation log, etc.. You can view, change, delete personal information and manage your authorization at "Settings". Register your product and enjoy the benefits. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. Register your device (s) on Philips' recall website . We understand that any change to your therapy device can feel significant. 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. 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. This recall notification/field safety notice has not yet been classified by regulatory agencies. 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. If you do not have a second device available we suggest you print out the instructions. 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). Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. .
Duration of Retention 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. 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. In some cases, this foam showed signs of degradation (damage) and chemical emissions. Below is the information you need to know on this recall, how you might be impacted, what next steps should be taken, and what you should expect. How can I register my product for an extended warranty? As we learn more, we will update our customers via email and the CPAP community at large using this blog. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. There are currently no items in your shopping cart. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). 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. You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Proof of purchase is a printed receipt from the shopwhere you purchased your product, or a PDF invoice from an online retailer. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Not all direct-to-consumer brands offer sales and discounts, though. Doing this could affect the prescribed therapy and may void the warranty. As a first step, if your device is affected, please start the registration process here. Below youll find a list of commonly asked questions about the CPAP recall. In that case, your use of the service provided in this application through collection of personal information may be restricted. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Your IP address is anonymized prior to use and storage within Apptentive's products and services. 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. As a result, testing and assessments have been carried out. Click Register. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation. Product Support: 800-685-2999. For further information about the Company's collection and use of personal information, please click the URL below. Dont have one? You are about to visit a Philips global content page. 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 . 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. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. Please know that your health and safety is our main priority, as we work through this process. We also offer frequent discounts on our machines, masks, and other CPAP accessories, which can help you save money on the equipment you need. 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. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. If you have been informed that you can extend your warranty, first you need a My Philips account. To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. Success. 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. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. 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. You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. We have notified all customers affected by the recall through email and each customer will shortly receive a physical mailed notice. We recommend you upload your proof of purchase, so you always have it in case you need it. We encourage you to read it if youre experiencing hardship during this recall. Are there any recall updates regarding patient safety? If the product does not perform after following the FAQs & troubleshooting steps. 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. What is the safety issue with the device? 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. 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. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. 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. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved
The Dream Family offers innovative, comprehensive sleep therapy technology like: . If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can still file a claim for reimbursement, but keep in mind that reimbursement is fully dependent on your insurance provider. Buying a CPAP machine outright offers several advantages and can be the most cost-effective option. The issue is with the foam in the device that is used to reduce sound and vibration. You can sign up here.
Enter the Captcha characters. Selected products 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. 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. Dont have one? 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.