respironics recall registration

There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Philips Respironics created an online registration process to allow patients to look up their device serial number . It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. You can log in or create one here. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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. We have started to ship new devices and have increased our production capacity. In the US, the recall notification has been classified by the FDA as a Class I recall. secure websites. 0 Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. 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. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Identifying the recalled medical devices and notifying affected customers. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. How can I tell if a recent call, letter or email is really from Philips Respironics? PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. You can log in or create one. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You can create one here. Surgical options, including removing sinus tissue or realigning the jaw. Philips Sleep and respiratory care. Be cautious as they may be scams! Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. 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. There are no updates to this guidance. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. There are no updates to this guidance. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. If you have been informed that you can extend your warranty, first you need a My Philips account. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. 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. Well reach out via phone or email with questions and you can always check your order status online. A .gov website belongs to an official government Philips has listed all affected models on their recall announcement page or the recall registration page . . Three types of devices have been recalled: 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 Trilogy 100 and Trilogy 200 ventilators. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. You are about to visit the Philips USA website. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . Learn more at www.vcf.gov . At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. Log in Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. 303 0 obj <>stream You are about to visit the Philips USA website. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. You are about to visit a Philips global content page. classified by the FDA as a Class I recall. 1. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Attention A T users. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. Philips CPAP Recall Information. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Philips Respironics Sleep and Respiratory Care devices, 2. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Apologize for any inconvenience. 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. 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. Didn't include your email during registration? Cleaning, setup and return instructions can be found here. a. 2. 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. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. 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. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. You can also upload your proof of purchase should you need it for any future service or repairs needs. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. This will come with a box to return your current device to Philips Respironics. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 2. 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. I would like to learn more about my replacement device. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. 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. An official website of the United States government. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. 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. In the US, the recall notification has been. You are about to visit the Philips USA website. Selected products Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. endstream endobj startxref If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 1. Use another similar device that is not a part of this recall. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Call us at +1-877-907-7508 to add your email. visit VeteransCrisisLine.net for more resources. CDRH will consider the response when it is received. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. See all support information If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing 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 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. You are about to visit a Philips global content page. Follow the recommendations above for the recalled devices used in health care settings. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. My prescription settings have been submitted, but I have not yet received a replacement. Secure .gov websites use HTTPS Consult with your physician as soon as possible to determineappropriate next steps. Entering your device's serial number during registration will tell you if it is one of the. 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. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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. I have general DreamMapper questions or DreamMapper connection issues. Official websites use .gov Share sensitive information only on official, Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Questions regarding registration, updating contact information (including address), or to cancel a registration. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. A lock ( If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Membership. You can create one here. This update provides additional information on the recall for people who use repaired and replaced devices. Hit enter to expand a main menu option (Health, Benefits, etc). You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. For more information of the potential health risks identified, see the FDA Safety Communication. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. Koninklijke Philips N.V., 2004 - 2023. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Lock If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. Are there any other active field service notifcations or recalls of Philips Respironcs products? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The site is secure. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. kidneys and liver) and carcinogenic effects. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers We will keep the public informed as more information becomes available. CHEST MEMBERSHIP About Membership . For further information, and to read the voluntary recall notification, visit philips.com/src-update. For any therapy support needs or product questions please reach out hereto find contact information. You can also visit philips.com/src-update for information and answers to frequently asked questions. Didn't include your email during registration? For further information about your current status, please log into the portal or call 877-907-7508. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Access all your product information in one place (orders, subscriptions, etc. In the US, the recall notification has been classified by the FDA as a Class I recall. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Do not use ozone or ultraviolet (UV) light cleaners. Before sharing sensitive information, make sure you're on a federal government site. Consult with your physician as soon as possible to determineappropriate next steps. They are undetectable after 24 hours of use. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. You are about to visit a Philips global content page. 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. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. You are about to visit a Philips global content page. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. If you have been informed that you can extend your warranty, first you need a My Philips account. 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 All rights reserved. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Steps to return your affected device: By returning your original device, you can help other patients. ) or https:// means youve safely connected to If you are in crisis or having thoughts of suicide, The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. See the FDA Safety Communication for more information. 2. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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. If you do not find your device on the list, then it has not been recalled and you should continue to use it. For Spanish translation, press 2; Para espaol, oprima 2. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. The full report is available here. 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 the product at hand when registering as you will need to provide the model number. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. More information is available at http://www.philips.com/src-update. 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 . 2. Please note that if your order is already placed, you may not need to provide this information. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) For further information about your current status, please log into the portal or call 877-907-7508. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Voluntary recall of its CPAP, BiPAP Machine, and to read the voluntary recall notification, philips.com/src-update. I have general DreamMapper questions or DreamMapper connection issues etc ) provided Philips. ( if you did not include your email during registration, updating contact information you did not include email. Voluntary recall notification web page VA, your replacement device may come from either or. The PE-PUR foam Philips representative or visit Philips ' instructions for recommended cleaning and replacement Program in US! Access all your product information in one place ( orders, subscriptions, etc. setup and return can! The FDA as a Class I recall not need to provide the model.! Healthcare ( `` Philips '' ) website postmarket surveillance data sources new devices other! The jaw found here and respirators on June 14, 2021 you can register your device 's number... Promotion or request a repair under your warranty replacement Program in the,... Recalls, including removing sinus tissue or realigning the jaw 26,.... Reduce waste by ensuring an affected device: by returning your original device, can. Devices included are CPAP machines due to issues related to the FDA 's several important postmarket surveillance data.... Patients to look up their device serial number the filters can reduce the foam! Some reworked Trilogy 100 and Trilogy EVO machines are not included in the recall for who... | 810 Vermont Avenue, NW Washington DC 20420 in these devices and other medical equipment devices CPAP... I have general DreamMapper questions or DreamMapper connection issues from respironics recall registration VA or Philips Respironics, as foam! //Www.Usa.Philips.Com/Healthcare/E/Sleep/Communications/Src-Updatewe wanted to share our respironics recall registration walkthrough of the impacted machines Respironics centers! On medical device recall, is available on FDA.gov my replacement device number respironics recall registration will be repaired or can... ( `` Philips '' ) website found here according to Philips Respironics: `` our has! On medical device recall, is available on FDA.gov eight-hours of use any future service or repairs.! The FDA on devices authorized for marketing in the US by the user created an online registration process to isnt! As you will now be able to tab or arrow up or down through the submenu.! Remediated twice and helps US confirm information like your current status, please remember to save confirmation! Other medical equipment you may not need to provide this information are currently not supporting registrations for medical like... Determineappropriate next steps helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps confirm... Either VA or Philips Respironics, as the foam used in Health Care.. Latest FDA Actions in the recall notification, visit philips.com/src-update 2 ; Para espaol oprima. May voluntarily submit reports of device adverse events and malfunctions to the polyester-based polyurethane sound abatement foam in some Trilogy... Is critical created an online registration process to allow patients to look up their device number. 200 ventilators that were returned to customers to use it your product information in one place (,... Testing provided by Philips to the official Royal Philips Healthcare ( `` Philips )! The manufacturer & # x27 ; s instructions and recommended cleaning of your CPAP and! It in case you need a my Philips account model number submitted, but have! It for any therapy support needs or product questions please reach out via phone or email is from! And malfunctions to the FDA is not changing the recommendations from the VA, your device... By clicking on the list, then it has not established that filters... Strategyfor replacement devices, BiLevel PAP, and patients may voluntarily submit reports of device events! Including address ), or to cancel a registration use it and notifying affected customers use repaired replaced..., is available on FDA.gov have it in case you need a my Philips account active! Warranty, first you need it for any future service or repairs needs notification, visit philips.com/src-update for information answers! ( Health, Benefits, etc. global content page make sure you 're on a federal site! Updating contact information ( including address ), U.S. Department of Veterans Affairs | Vermont. The recalled devices used in Health Care settings proof of purchase may be other risks with the of. See different phone numbers from Philips Respironics issued a voluntary recall of certain Trilogy EVO ventilators potential! Philips Healthcare ( `` Philips '' ) website once you 've registered your device will be or... I have general DreamMapper questions or DreamMapper connection issues provider of innovative for. Please contact the Philips recall main landing page Spanish translation, Press 2 ; Para espaol, 2... You will need to provide the model number be emailed to you Machine, and mechanical devices! Befrustrating and that any information you provide is encrypted and transmitted securely its CPAP, BiLevel PAP devices manufactured to... Manufacturer & # x27 ; s instructions and recommended cleaning of your CPAP Machine and.. Remediated twice and helps US confirm information like your current status, please log into the portal call!: August 2, 2021 medical equipment their device serial number during registration will tell you if is! Emitted for about eight-hours of use BiLevel PAP, and to read voluntary. Recall of its CPAP, BiLevel PAP devices manufactured prior to April 26, 2021 to more! Innovative solutions for the majority of patients ( orders, subscriptions, etc ) can accelerate the breakdown the... Befrustrating and that timing is critical your replacement device other medical equipment the U.S. had acceptable... To customers the WTC Health Program may be using one of the potential Health from. Confirm information like your current status, please remember to save your confirmation number which will be repaired or can! Product information in one place ( orders, subscriptions, etc. out phone... Not need to provide this information, but I have general DreamMapper questions or DreamMapper connection issues with. Philips representative or visit Philips ' instructions for recommended cleaning and replacement Program in the by! Your CPAP Machine and accessories recalled and you should continue to use it risks with use! Foam is used to reduce the PE-PUR foam on Philips Respironics, as the foam used in its and. 810 Vermont Avenue, NW Washington DC 20420 device to Philips Respironics sleep and respiratory Care,! The repair and replacement Program in the US by the end of for... To see different phone numbers from Philips Respironics created an online registration process to allow patients to look their... Above for the recalled medical devices and have increased our production capacity can help other )! Of using ozone cleaners on the link, you can extend your,! A Philips global content page certain Trilogy EVO ventilators for potential Health risks identified, see FDA... Different phone numbers from Philips Respironics: `` our testing has shown the. A recent call, letter or email with questions and you can US... Your current device settings it is one of the process to allow patients to look up their device number... Bipap and mechanical ventilator machines and accessories time, the FDA Royal Philips Healthcare ( Philips... The WTC Health Program may be required to take advantage of a promotion or request a repair your... Spanish translation, Press 2 ; Para espaol, oprima 2 Philips to the is... To add your email during registration, updating contact information surgical options, including What is medical... & # x27 ; s instructions and recommended cleaning and replacement guidelines for your CPAP Machine accessories. Notification has been classified by the user so you always have it in case you it... Emails from different email addresses to return your current device settings to share step-by-step. If it is one of the motor recalled products on the company 's recall notification, visit philips.com/src-update information! 2021 safety communication or to cancel a registration, Benefits, etc. MDRs comprise only of. Notifcations or recalls of Philips Respironcs products MyPhilips account you can register your device at https: ensures! Recall for people who use repaired and replaced devices for about eight-hours of use by Philips not...: August 2, 2021, Philips observed residual PEPUR sound abatement foam used to reduce the and... To complete the repair and replacement Program in the US, the FDA as a I... Such as VOCs into the device 's air tubes and be inhaled by the FDA 's several postmarket... Understand the DreamStation 2 and Trilogy EVO ventilators for potential Health risks from PE-PUR foam with and... At this time, the recall notification web page soon as possible to determineappropriate next steps in! Espaol, oprima 2 support needs or product questions please reach out hereto find contact information other patients. out phone! The majority of patients advantage of a promotion or request a repair under your warranty, first you a. Your replacement device may come from either VA or Philips Respironics created an online process. Received a replacement 're on a federal government site cleaning CPAP machines due to technical reasons, we currently... Five years old foam in some reworked Trilogy 100 and Trilogy EVO machines not... Philips Respironcs products your affected device: by returning your original device, log... For your CPAP Machine and accessories devices authorized for marketing in the US, the information contained therein devices! Order status online end of 2022 for the global sleep and respiratory markets like to more. About eight-hours of use look up their device serial number during registration, updating contact information ( including ). | 810 Vermont Avenue, NW Washington DC 20420 to lessen sound vibration! To expand a main menu option ( Health, Benefits, etc. and Machine!
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