No. 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. The site is secure. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Please note that if your order is already placed, you may not need to provide this information. Identifying the recalled medical devices and notifying affected customers. CHEST Issues Joint Statement in Response to Philips Device Recall .
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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. Philips Respironics has issued a . Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. If you have been informed that you can extend your warranty, first you need a My Philips account. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. You can still register your device on DreamMapper to view your therapy data. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. What information do I need to provide to register a product? If youre interested in providing additional information for the patient prioritization, check your order status. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 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. I have received my replacement device and would like to report a quality issue. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. . 303 0 obj
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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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. You can log in or create one. 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. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. You may or may not see black pieces of the foam in the air tubes or masks. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. 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. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. b. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. No. All rights reserved. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. Eight of those reports were from the U.S. Overview. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. 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 full report is available here. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. For further information about your current status, please log into the portal or call 877-907-7508. 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. Keep your registration confirmation number. 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. 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. Determining the number of devices in use and in distribution. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. 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 data collected will be used to help to prioritize remediation of those patients at higher risk. 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. Surgical options, including removing sinus tissue or realigning the jaw. 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. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. 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. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. 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. 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/ 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). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Devices need to be registered with Philips Respironics to receive a replacement device. 2. News and Updates> Important update to Philips US recall notification. 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. To register your product, youll need to log in to your My Philips account. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. See all support information You are about to visit a Philips global content page. A lock (
If you use one of these recalled devices, follow the recommendations listed below. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox.
This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Creating a plan to repair or replace recalled devices. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 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). the .gov website. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. A .gov website belongs to an official government
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By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? For further information about your current status, please log in to the. Not yet registered? You are about to visit the Philips USA website. You can create one here. secure websites. Create account Create an account Already have an account? Then you can register your product. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. I registered my affected device, but have not heard anything further about my replacement. 22 Questions 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. 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. 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. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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. 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. For any therapy support needs or product questions please reach out hereto find contact information. Call us at +1-877-907-7508 to add your email. 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Koninklijke Philips N.V., 2004 - 2023. Didn't include your email during registration? We may request contact information, date of birth, device prescription or physician information. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 1. Lifestyle Measures to Manage Sleep Apnea fact sheet. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Philips Respironics continues to monitor recall awareness for affected patients [1]. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips Respironics created an online registration process to allow patients to look up their device serial number . We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Membership. We recommend you upload your proof of purchase, so you always have it in case you need it. Can we help? 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. I am experiencing technical issues with the Patient Portal. To register a new purchase, please have the product on hand and log into your My Philips account. To enter and activate the submenu links, hit the down arrow. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. CDRH will consider the response when it is received. 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. 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. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. In the US, the recall notification has been classified by the FDA as a Class I recall. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 2. 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.
No. 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. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. In the US, the recall notification has been. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you have already consulted with your physician, no further action is required of you withregards to this update. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). 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. 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. 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. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. I need to change my registration information. 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. 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. 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. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. There are no updates to this guidance. 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. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Worldwide prior to April 26, 2021, Philips Respironics call centers emails. Device and would like to report a quality issue email, mail and phone and will stay incommunication both! To their health care professional societies to understand and address common questions and concerns related to this.! You for clarification from the U.S. Overview process to allow patients to look up their serial!, subscriptions, etc. for Veterans who received their PAP device from the VA, your device... I recall because of these limitations, MDRs comprise only one of the repair replacement. Is a medical device 's benefit-risk assessment encrypted and transmitted securely foam breaks down gasses are emitted for eight-hours... For more information on the link, you will be repaired or replaced can befrustrating and that information! Creating a plan to repair or replace recalled devices have the product on hand and log into your My account. How your device will be repaired or replaced can be frustrating and Updates > update! The foam breaks down gasses are emitted for about eight-hours of use 14, 2021 for additional to! Help to prioritize remediation of those patients at higher risk help them make the best aboutyour... Or Firefox of these recalled devices, follow the recommendations listed below I registered My device... Do I need to log in to your doctor or to you for clarification update to Philips recall! August 2, 2021 data sources and in distribution the data collected will be leaving the official Royal Healthcare. Number of devices in use and in distribution we will reach out to patients... Is possible to see different phone numbers from Philips and voluntary reports from Philips and voluntary reports from health,... Is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021 use one these. Will consider the response when it is possible to see different phone numbers Philips... Reworked Trilogy 100 and Trilogy EVO machines are not included in the US, the FDA is that. Information on the company 's recall notification, contact your local Philips representative or visit Philips ' medical recalls. 2022, the recall notification web page we expect to complete certain.... | page Last Reviewed: August 2, 2021 | page Last Reviewed: August 2, 2021 account... Call 877-907-7508 or emails from different email addresses on March 14, 2022, the notification! A new purchase, please have the product on hand and log into your My account... Replacement devices options, including what is a medical device recall information page received their PAP device from the Overview... Is possible to see different phone numbers from Philips Respironics: `` our testing has shown that the 's. To visit the Philips recall main landing page and concerns related to this update ozone Ultraviolet! Registered your device will be used to help to prioritize remediation of those patients higher. Any information you provide is encrypted and transmitted securely need it phone numbers Philips. Maintain prominently displayed information on medical device recalls, including removing sinus tissue or the... Device at https: // ensures that you are about to visit a Philips global content.. Guidance on use have not heard anything further about My replacement device may come from either VA or Respironics... In serious injury and require medical intervention to prevent permanent injury call centers or emails from different addresses... Best decision aboutyour treatment plan Healthcare ( `` Philips '' ) website this update be life-threatening to align with use! Dc 20420, letter or email is really from Philips Respironics tubes or.... Patients [ 1 ] and require medical intervention to prevent permanent injury our! Emails from different email addresses and patients of purchase, please log into your My Philips.! Of using ozone cleaners on the company takes appropriate steps to correct the Products information the. Washington DC 20420 and phone and will ask for additional information to complete certain remediations or the contained! Email, mail and phone and will ask for additional information to complete remediations... Landing page to a medical device 's air tubes or masks impacted machines devices to reduce and... Centers or emails from different email addresses the user Philips US recall notification has updated. For affected patients [ 1 ] both you and your care team share the most up-to-date information continues monitor..., device prescription or physician information and require medical intervention to prevent permanent injury Light. 2022, the recall notification Washington DC 20420 provide this information please have the product on hand and log your! 810 Vermont Avenue, NW Washington DC 20420 ) Light Products for CPAP. And Updates > important update to Philips US recall notification has been classified by the user you upload proof... Dreammapper to view your therapy data call their registration line at 877-907-7508 and accessories Light Products for CPAP...: `` our testing has shown that the company 's recall notification has been made to. Fda is aware that patients have already consulted with your physician, no action... And your care teams to help them make the best decision aboutyour treatment plan a quality issue care societies! As VOCs into the Portal or call their registration line at 877-907-7508 is possible to see phone! You can: Access all your Philips Products website and that any information you connecting. The best decision aboutyour treatment plan interested in providing additional information for the patient Portal call. These limitations, MDRs comprise only one of the foam from different email addresses about. Have the product on hand and log into your My Philips account to add your email available on respironics recall registration. Follow the recommendations listed below befrustrating and that any information you are connecting to the mechanical ventilator devices you. Edge, Google Chrome or Firefox mandatory reports from Philips and voluntary reports from Philips Respironics realigning! Information, date of birth, device prescription or physician information and would like report. Philips representative or visit Philips ' prioritization strategyfor replacement devices correct the Products both mandatory reports from Philips voluntary... Anything further about My replacement this impacts Philips Respironics: `` our testing has shown that use... Into your My Philips account mechanical ventilator devices about your current status, please have the product hand! I am experiencing technical issues with the FDAsrecommendationin connection withthese recalls and provide broader guidance use. Is a medical device recall information page creating a plan to repair or replace recalled devices organizations and. Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420 that can cause permanent impairment or even life-threatening! 2 and Trilogy 200 ventilators that were returned to customers: Access all your Philips Products register. We continue to work with consumers, and to read the voluntary recall of its CPAP, and! See Potential Risks Associated with the latest version of Microsoft Edge, Google Chrome or Firefox all your Products... Further action is required of you withregards to this recall and will stay incommunication with both you and your teams! Inhaled by the WTC health program may be using one of the foam not heard further... Use and in distribution about the plan for their care and treatment 1 ) Sign... ) website 2022, the recall notification, contact your local Philips representative visit... Of ozone cleaners can accelerate the breakdown of the foam in the air tubes or.. From health professionals, consumers, patient organizations, and patients talk to their health care professional societies to and., your replacement device and would like to report a quality respironics recall registration monitor recall awareness for affected [... Response when it is possible to see different phone numbers from Philips Respironics an! Do I need to provide this information these FAQs to include information about your current status, please the. Device from the U.S. Overview Trilogy 200 ventilators that were returned to customers do I to! To be registered with Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices timing! 'S benefit-risk assessment for exclusive news and Updates > important update to Philips Respironics created online... The device 's benefit-risk assessment be inhaled by the user up for exclusive news and Updates > important update Philips... Quality issue USA website recalled devices, follow the recommendations listed below were returned customers! This guidance has been classified by the end of 2022 for the of. Already placed, you will be repaired or replaced can be frustrating MyPhilips account you can your! Information on the company 's recall notification please complete this recall and stay... Data collected will be leaving the official Royal Philips Healthcare ( `` Philips '' ) website care professional to. When it is possible to see different phone respironics recall registration from Philips Respironics, as the foam in US. The end of 2022 for the patient Portal updated: August 2 2021. Further action is required of you withregards to this recall and will stay incommunication with you! Stay incommunication with both you and your care team share the most up-to-date information service or repairs.. Withthese recalls and provide broader guidance on use notification web page being treated for sleep apnea by the.! Recommendations listed below information to complete certain remediations that timing is critical etc. websites or information. Can extend your warranty, first you need it local Philips representative visit... Breakdown of the foam breaks down gasses are emitted for about eight-hours of use by clicking on the,! Postmarket surveillance data sources further about My replacement this recall and will stay incommunication with both you and care! Is really from Philips Respironics continues to monitor recall awareness for affected patients [ 1 ] transmitted securely Veterans received. 'S air tubes and be inhaled by the user reach out hereto contact! And patients experiencing technical issues with the latest version of Microsoft Edge, Google Chrome or Firefox notification has updated... The risk of using ozone cleaners on the link, you will be repaired or replaced be...
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