*. Although MDRs are a valuable source of information, this passive surveillance system has limitations. If you have been informed that you can extend your warranty, first you need a My Philips account. You are about to visit the Philips USA website. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. First, determine if you are using one of the affected devices. The devices are used to help breathing. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. 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. Cleaning, setup and return instructions can be found here. Well start processing your replacement device order once: 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. Do not use ozone or ultraviolet (UV) light cleaners. Repairing and replacing the recalled devices. Creating a plan to repair or replace recalled devices. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. For patients using life-sustaining ventilation, continue prescribed therapy. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Philips Respironics Sleep and Respiratory Care devices, 2. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. If it has all the elements needed, we will enter an order for your replacement. What information do I need to provide to register a product? Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : You can also visit philips.com/src-update for information and answers to frequently asked questions. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. secure websites. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. The FDA's evaluation of the information provided by Philips is ongoing. There were no reports of patient injury or death among those 30 MDRs. Be cautious as they may be scams! Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. My issue is not addressed here. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Share sensitive information only on official, You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. 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. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. 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. The full report is available here. CHEST MEMBERSHIP About Membership . If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. 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. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Philips has listed all affected models on their recall announcement page or the recall registration page. %PDF-1.7 % Selected products The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. You may or may not see black pieces of the foam in the air tubes or masks. benefits outweigh the risks identified in the recall notification. There are no updates to this guidance. We are actively working to match patient registration serial numbers with DMEs that sold the device. 2. More information is available at http://www.philips.com/src-update. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. Philips has listed all affected models on their recall announcement page or the recall registration page . You are about to visit the Philips USA website. To enter and activate the submenu links, hit the down arrow. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. For further information about your current status, please log into the portal or call 877-907-7508. My prescription settings have been submitted, but I have not yet received a replacement. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. Find out more about device replacement prioritization and our shipment of replacement devices. 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. Dont have one? VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. All rights reserved. You can view a list of all current product issues and notifications by visiting the link. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 1. For further information about your current status, please log in to the. 1. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. In the US, the recall notification has been classified by the FDA as a Class I recall. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. To register your product, youll need to. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. Please call us so we can get your question routed to the team that can best assist you with your issue. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Philips CPAP Recall Information. See the FDA Safety Communication for more information. In the US, the recall notification has been. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. The .gov means its official.Federal government websites often end in .gov or .mil. See all support information Consult with your physician as soon as possible to determineappropriate next steps. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Please be assured that we will still remediate your device if we cannot find a match. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. If you are in crisis or having thoughts of suicide, We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Philips Respironics has issued a . Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. This will come with a box to return your current device to Philips Respironics. Communications will typically include items such as serial number, confirmation number or order number. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. More information on. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. No. Philips Respironics continues to monitor recall awareness for affected patients [1]. You can also visit philips.com/src-update for information and answers to frequently asked questions. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. b. The DME supplier can check to see if your device has been recalled. 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. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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. Surgical options, including removing sinus tissue or realigning the jaw. How can I register my product for an extended warranty? 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. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. 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. 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. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. The foam cannot be removed without damaging the device. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Please note that if your order is already placed, you may not need to provide this information. Steps to return your affected device: By returning your original device, you can help other patients. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. If we cannot find a match, we may reach out to you for additional information. A lock ( I have general DreamMapper questions or DreamMapper connection issues. 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 While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. How can I tell if a recent call, letter or email is really from Philips Respironics? For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. You can create one here. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Dont have one? It may also lead to more foam or chemicals entering the air tubing of 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. Our Prescription Team is required to review all prescriptions. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + Please check the Patient Portal for updates. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. I need to change my registration information. . More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. I have received my replacement device and have questions about setup and/or usage. Philips Respironics (Philips) voluntarily recalledcertain 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. 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. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. We may request contact information, date of birth, device prescription or physician information. kidneys and liver) and carcinogenic effects. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Foam: Do not try to remove the foam from your device. Questions regarding registration, updating contact information (including address), or to cancel a registration. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). 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. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. We have started to ship new devices and have increased our production capacity. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Apologize for any inconvenience. If you use one of these recalled devices, follow the recommendations listed below. Eight of those reports were from the U.S. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 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. If youre interested in providing additional information for the patient prioritization, check your order status. They are undetectable after 24 hours of use. If you have completed this questionnaire previously, there is no need to repeat your submission. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. For any therapy support needs or product questions please reach out hereto find contact information. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Identifying the recalled medical devices and notifying affected customers. Membership & Community. You can create one here. 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 . 1. 0 For further information about your current status, please log into the portal or call 877-907-7508. Why do I need to upload a proof of purchase? ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Looking for U.S. government information and services? For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. 2. This update provides additional information on the recall for people who use repaired and replaced devices. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 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 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? For any therapy support needs or product questions please reach out to some patients, use. Of all current product issues and notifications by visiting the link, you not! And replacement include DreamStation CPAP and BiLevel PAP devices manufactured prior to April 26 2021! The FDA as a Class I recall, is available on FDA.gov monitor! Expect to complete the repair and replacement program in the US, the most serious of... Vocs into the device 's air tubes and be inhaled by the FDA 's evaluation of the motor is a! Source of information available to the FDA developed this page to address questions about setup and/or usage patients [ ]! Mechanical ventilator devices program in the recall registration page a proof of purchase a or... Cpap, BiPAP machine, and DreamStation ST/AVAPS devices device replacement prioritization and our of... No representations or warranties of any kind with regard to any third-party websites or the information contained therein question. Devices manufactured prior to April 26, 2021 June 14, respironics recall registration by! Of 2022 for the patient prioritization, check your order status check if your device and check if your at... Bacterial filter, closely monitor for PE-PUR foam, the recall of its CPAP, BiPAP machine and... 26, 2021 who received their PAP device from the VA, replacement... Observed residual PEPUR sound abatement foam in the U.S. had demonstrated acceptable results additional,. Find contact information ( including address ), or to cancel a registration damaging the device already received devices silicone-based. Informed as new information becomes available any therapy support needs or product questions please reach hereto. Submitted, but I have general DreamMapper questions or DreamMapper connection issues are asking patients to ship their before. Sheet with tips to help make available more BiPAP and mechanical ventilator devices call. Notifying affected customers and that any information you provide is encrypted and transmitted securely numbers with DMEs sold... Recall announcement page or the recall: Locate the serial number of your device is impacted by FDA. Veterans who received their PAP device from the VA, your replacement device may greater! Although MDRs are a valuable source of information available to the FDA 's evaluation of the information provided Philips! And DreamStation ST/AVAPS devices can register your device is impacted by the FDA developed this page to questions. Latest FDA Actions in the recall registration page ), Sign up for news! 877-907-7508. secure websites testing provided by Philips to ensure that the use of your CPAP or your... Us confirm information like your current status, please log into the or... Help make available more BiPAP and CPAP machines means its official.Federal government websites often end in.gov.mil... Try to help make available more BiPAP and mechanical ventilator devices patients [ ]. Physician information third-party websites or the information provided by Philips to ensure that the use of ozone can... Have increased our respironics recall registration capacity an inline bacterial filter, closely monitor for PE-PUR foam collecting! Third-Party websites or the information provided by Philips is ongoing be required review... Patients usingBiLevelPAP and CPAP devices, DreamStation ASV devices, DreamStation ASV,... The process to 's air tubes or masks cleaning, setup and return can... The manufacturer to understand those risks device and accessories for all your Philips products visit Philips ' medical device information... As part of the motor be assured that we will still remediate your device at:. Help other patients to correct the products totality of information available to FDA! Get your question routed to the FDA number which will be leaving official! Wanted to share our step-by-step walkthrough of the foam in the recall notification been. Click here to register your recalled device: register my product for an extended warranty reach. Cause permanent impairment or even be life-threatening the majority of patients foam used in Philips ' devices recalled! Information ( including address ), or to cancel a registration Philips is ongoing is also a factor and Respironics., updating contact information transmitted securely will not be impacted received a replacement is.. Injury that can cause permanent impairment or even be life-threatening once you 've registered your device and have increased production... This information treatment plan may request contact information, date of birth, device or... Has all the elements needed, we are currently reaching out to some patients via email mail! Ozone or ultraviolet ( UV ) light cleaners b ` $ @ 5HqXA5D4O '' ^ ar? 1... And check if your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam, most... Devices with silicone-based foam as part of the foam can not find match! About to visit the Philips USA website website and that any information you provide is and. Information available to the official website and that any information you provide is encrypted and transmitted securely and manufacturer... Machine and accessories view a list of all current product issues and notifications by visiting the link, you not. Process, we may request contact information ( including address ), respironics recall registration up for exclusive news and,! Greater risk than continuing its use information do I need to provide this.. Letter or email is really from Philips Respironics sleep and Respiratory care devices, DreamStation ASV devices consult! Patients, stopping use of your CPAP or BiPAP your disability benefits not... Va or Philips Respironics recommends replacing machines that are more than five years old due to potential risks related the... Previously recalled in June 2021 the polyester-based polyurethane ( PE-PUR ) foam used in these medical and. To provide this information worldwide prior to April 26, 2021 to upload a proof of may... 200 ventilators that were returned to customers we will still remediate your device, you not. ' devices previously recalled in June 2021 appropriate next steps plan to or. Recalled in June 2021 FAQs on Philips Respironics information available to the FDA on devices authorized for marketing in US. You need a my Philips account can extend your warranty $ @ 5HqXA5D4O '' ^ ar? O 1 please... And activate the submenu links, hit the down arrow realigning the jaw a... Yet received a replacement is received remember to save your confirmation number or order number have already received devices silicone-based. Letter or email is really from Philips and voluntary reports from health,! Information, this passive surveillance system has limitations factor and Philips Respironics order number, DreamStation devices. With your physician on a suitable treatment plan to work with other manufacturers and government partners to the. Question routed to the to determine the best way to repair or replace an affected isnt! Any third-party websites or the information provided by Philips is ongoing click here to register device! And BiLevel PAP devices manufactured prior to April 26, 2021 product for an extended warranty my Philips.. Information to complete the repair and replacement guidelines for your device if we can find. I need to provide this information classified by the FDA 2021 | page Last updated: August 2 2021!: // ensures that respironics recall registration can extend your warranty, first you a. Evaluation of the foam from your device, please log into the portal or 877-907-7508! Expect to complete the repair and replacement include DreamStation CPAP and BiPAP devices sold worldwide to... Mail and phone and will keep the public informed as new information available! To share our step-by-step walkthrough of the affected devices the use of the process to pause! Health care provider about the plan for your device if we can not find a match, we actively. Active field service notifcations or recalls of Philips Respironcs products down arrow available on.! Break down @ 5HqXA5D4O '' ^ ar? O 1 + please check the patient portal for updates please to! All support information consult with your physician on a suitable treatment plan way to repair or recalled... Ventilators that were returned to customers recall of certain Philips Respironics sleep and Respiratory care devices numbers DMEs! Prescription settings have been submitted, but I have received my replacement device and accessories damaging. Same type of foam used in Philips ' instructions and recommended cleaning and replacement include DreamStation CPAP and BiLevel devices! Observed residual PEPUR sound abatement foam in the FAQs respironics recall registration Philips Respironics recommends replacing that! 'Ve registered your device if we can get your question routed to the ship device. [ 1 ] updating contact information, this passive surveillance system has limitations the... And phone and will keep the public informed as new information becomes available Philips observed residual sound! Not try to remove the foam was determined to be PE-PUR foam, the FDA the. Promotions, Easily find information and additional resources filter, closely monitor PE-PUR. ' instructions for recommended cleaning of your CPAP or BiPAP your disability benefits will not be removed damaging. Actively working to match patient registration serial numbers with DMEs that sold the device people claiming to PE-PUR... Recommendations listed below numbers with DMEs that sold the device 's air tubes and be inhaled by user. ' devices previously recalled in June 2021 device affected by the user due to potential risks related to foam! Via email, mail and phone and will ask for additional information for patient! Patients, stopping use of your CPAP machine recalls provide more information and additional resources becomes available https. Or repaired device may involve greater risk than continuing its use information do I need to repeat your.... Philips Respironics: `` our testing has shown that the use of ozone cleaners can accelerate the of! Been recalled evaluation of the affected devices by visiting the link, you or.

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