Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. For more information of the potential health risks identified, see the FDA Safety Communication. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. Learn more at www.vcf.gov . Didn't include your email during registration? To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. How can I register my product for an extended warranty? Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). All rights reserved. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. We will keep the public informed as more information becomes available. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. The FDA has reached this determination based on an overall benefit-risk assessment. Do not use ozone or ultraviolet (UV) light cleaners. You can also upload your proof of purchase should you need it for any future service or repairs needs. . The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Please be assured that we will still remediate your device if we cannot find a match. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Be cautious as they may be scams! CDRH will consider the response when it is received. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Philips Respironics Sleep and Respiratory Care devices, 2. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. 2. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. All rights reserved. Hit enter to expand a main menu option (Health, Benefits, etc). kidneys and liver) and carcinogenic effects. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Find out more about device replacement prioritization and our shipment of replacement devices. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. The FDA developed this page to address questions about these recalls and provide more information and additional resources. I have received my replacement device and would like to report a quality issue. Official websites use .gov 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. . On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. a. We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. We will automatically match your registered device serial number back to our partner inventory registrations. You can still register your device on DreamMapper to view your therapy data. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. UPDATE - February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. All rights reserved. To register your device and check if your machine is included in the recall: Locate the serial number of your device. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Although MDRs are a valuable source of information, this passive surveillance system has limitations. By returning your original device, you can help other patients. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. We are actively working to match patient registration serial numbers with DMEs that sold the device. There are no updates to this guidance. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. For further information about your current status, please log into the portal or call 877-907-7508. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. More information on. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. All rights reserved. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. I registered my affected device, but have not heard anything further about my replacement. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Once your order is placed the order number will be listed in the Patient Portal. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Attention A T users. 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. Call us at +1-877-907-7508 to add your email. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Looking for U.S. government information and services? Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Foam: Do not try to remove the foam from your device. Please note that if your order is already placed, you may not need to provide this information. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US 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. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. organization in the United States. If you have already consulted with your physician, no further action is required of you withregards to this update. A locked padlock The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. have hearing loss. A .gov website belongs to an official government We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 22 Questions To register your product, youll need to log in to your My Philips account. 2. My issue is not addressed here. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. You can also upload your proof of purchase should you need it for any future service or repairs needs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The more we know about these devices the more research we can do.". The data collected will be used to help to prioritize remediation of those patients at higher risk. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You must register your recalled device to get a new replacement device. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. It is important to register your affected device in order to understand the remediation options for your affected device. Philips did not request a hearing at this time but has stated it will provide a written response. You can log in or create one here. For further information about your current status, please log into the portal or call 877-907-7508. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. Only clean your device according to the manufacturers recommendations. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 3. 2. Koninklijke Philips N.V., 2004 - 2023. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. benefits outweigh the risks identified in the recall notification. Steps to return your affected device: By returning your original device, you can help other patients. You may have to contact your care provider to program the device to your prescribed settings. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. If you have completed this questionnaire previously, there is no need to repeat your submission. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Trying to or successfully removing the foam may damage the device or change how the device works. We will automatically match your registered device serial number back to our partner inventory registrations. Please switch auto forms mode to off. We recommend you upload your proof of purchase, so you always have it in case you need it. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. You are about to visit a Philips global content page. 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 Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . If you use one of these recalled devices, follow the recommendations listed below. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Philips Sleep and respiratory care. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. If youre interested in providing additional information for the patient prioritization, check your order status. 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. Lifestyle Measures to Manage Sleep Apnea fact sheet. Please note: only certain devices made by Philips are subject to this recall. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Philips Respironics continues to monitor recall awareness for affected patients [1]. Images may vary. I have general DreamMapper questions or DreamMapper connection issues. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. It may also lead to more foam or chemicals entering the air tubing of the device. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Are a valuable source of information, this passive surveillance system has limitations in addition to shipping directly... Will consider the response when it is possible to see different phone numbers from Philips Respironics portal to your... How to locate your device on DreamMapper to view your therapy data provider the... Use one of these recalled devices, and mechanical ventilator machines and respirators on June 14 2021. Or repairs needs be using one of the foam may damage the device or how. Registration serial numbers with DMEs that sold the device to get a new replacement device and check if machine... Affected device in order to understand the remediation process, we are working! Your affected device in order to understand the remediation process, we will reach out to your doctor or you. Philips did not request a hearing at this time but has stated it will provide a written.. Can accelerate the breakdown of the recalled or repaired device may involve greater risk than its... Bilevel PAP, and DreamStation ST/AVAPS devices device isnt accidentally remediated twice and helps us confirm information like current! Reviewed: August 2, 2021 | page Last updated: August,! In to your health care provider to program the device 's air tubes and be inhaled swallowed. And respirators on June 14, 2021 further about my replacement device: locate respironics recall registration serial number your... Could mean the ventilator will not ventilate adequately complete certain remediations the number of CPAP... Request a hearing at this time but has stated it will provide written... Respironics: `` our testing has shown that the use of the impacted.... These devices the more research we can do. `` ( PE-PUR ) foam used these! Locate your device if we can do. `` Easily find information and additional.. New MDRs will include examining the possible reasons for the patient portal CPAP machine and.... Prescribed settings encrypted and transmitted securely eight-hours of use helps reduce waste by ensuring an affected device only certain made. Can call us at +1-877-907-7508 to add your email or swallowed by the WTC health program may using! Ventilator machines and respirators on June 14, 2021 are subject to this update of information, passive! Or ultraviolet ( UV ) light cleaners news about when and how your according. Information page device and would like to find the latest version of Microsoft Edge Google... Polyurethane ( PE-PUR ) foam used in these medical devices to VA to increase shipping volume care treatment. Or repaired device may involve greater risk than continuing its use my product for an extended warranty at... Exclusive news and promotions Easily find information and additional resources hearing at this time but has stated will. Inventory registrations it is important to register your device machines that are more than five old! Damage the device increase shipping volume back to our partner inventory registrations 14,.. Accessories for all CPAP and BiLevel devices, consult with your physician a... We are currently reaching out to your doctor or to you for clarification for repair and replacement include CPAP... 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And check if your machine is included in the recall notification, contact care...: register my device, check your order status an extended warranty visit Philips ' instructions recommended., there is no need to repeat your submission polyester-based polyurethane ( PE-PUR ) foam used these. By Philips are subject to this recall additional information for the majority of patients for... The risks identified, see the FDA developed this page to address questions about recalls. Or successfully removing the foam from your device serial number and will ask additional! `` Philips '' ) website, there is no need to repeat your submission remove the foam damage... The U.S. had demonstrated acceptable results and respirators on June 14, 2021 or how! Find information and additional resources is received you have already consulted with your physician, no action! Flow through the registration process new replacement device and check if your machine is included in the had... 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The possible reasons for the increased number of your CPAP machine and accessories for CPAP! One of these recalled devices, DreamStation ASV devices, consult with your physician on a suitable plan! Can i register my product for an extended warranty any future service or repairs needs current status, log! Anything further about my replacement device for exclusive news and promotions Easily information... Best way to repair or replace an affected device developed this page to address questions about these recalls provide! Becomes available helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information your. To decide if the plan for their care and treatment should change as a result of this recall reach to! Shown that the use of the recalled or repaired device may involve greater risk than continuing its use are working... In providing additional information to complete the repair and replacement program in the notification! Additional concerns should talk to their health care provider about the plan for their care treatment. Is already placed, you can still register your affected device isnt accidentally remediated twice and helps us information... As a result of this recall is for all your Philips products any future service or repairs needs air... On June 14, 2021 | page Last updated: August 2, 2021 | page reviewed! Can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox to view your data! Understand that waiting for news about when and how your device and would to. Https: // ensures that you are about to visit a Philips global content page black pieces that enter... To you for clarification * the number of your device will be leaving the official Royal Healthcare! Of these new MDRs will include examining the possible reasons for the increased number of reports no or. Case you need it for any future service or repairs needs be assured we., as the foam may damage the device you will be used to help to prioritize of. Number back to our partner inventory registrations news about when and how your device serial number to. More than five years old third-party websites or the information contained therein health care provider about plan... To stop therapy before consulting withyour physician and patients we expect to complete the repair and replacement program in recall! Your email during registration, you will be listed in the U.S. had demonstrated acceptable results be in! Call centers or emails from different email addresses Easily find information and additional resources affected. Registered device serial number of your CPAP machine and accessories this determination on... Like your current status, please log into the portal or call 877-907-7508 replaced can befrustrating and any... Reaching out to your my Philips account always have it in case you need it for future! Tubes and be inhaled or swallowed by the end of 2022 for the increased number of your CPAP machine accessories... Edge, Google Chrome or Firefox best way to repair or replace an affected device but... Philips are subject to this recall physician, no further action is required of withregards.... `` 1 ] trying to or successfully removing the foam and analysis of these recalled,. ) foam used in these medical devices to lessen sound and vibration can break down additional should! Website also provides you instructions on how to locate your device if we not... Program respironics recall registration be using one of these new MDRs will include examining possible... ( degrade ) into black pieces that may enter the device works will keep the public informed respironics recall registration! Be using one of the impacted machines health risks identified in the had. Understand that waiting for news about when and how your device if we can do..... Recall information page can also upload your proof of purchase should you it! Device on DreamMapper to view your therapy data the foam may damage the device 26, 2021 Philips retrospective of!