We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. If youre interested in providing additional information for the patient prioritization, check your order status. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. 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. Philips has listed all affected models on their recall announcement page or the recall registration page. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Register your product and start enjoying benefits right away. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. 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. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. We are investigating potential injury risks to users, including several cancers. CDRH will consider the response when it is received. It is important to register your affected device in order to understand the remediation options for your affected device. 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. 2. 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. 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. You can also visit philips.com/src-update for information and answers to frequently asked questions. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Apologize for any inconvenience. I would like to learn more about my replacement device. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Veterans Crisis Line: 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Attention A T users. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Lock 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. We recommend you upload your proof of purchase, so you always have it in case you need it. Please visit the Patient Portalfor additional information on your status. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. If youre interested in providing additional information for the patient prioritization, check your order status. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. Surgical options, including removing sinus tissue or realigning the jaw. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Philips has listed all affected models on their recall announcement page or the recall registration page . Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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 FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. You can also visit philips.com/src-update for information and answers to frequently asked questions. Call us at +1-877-907-7508 to add your email. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. %%EOF You are about to visit a Philips global content page. endstream endobj startxref organization in the United States. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. A .gov website belongs to an official government Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. In this video, we will be going into detail about the process to register your device on the Philips website. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Cleaning, setup and return instructions can be found here. The FDA's evaluation of the information provided by Philips is ongoing. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The relevant heath information that will be asked includes: An occupation associated with public safety. How can I tell if a recent call, letter or email is really from Philips Respironics? You can still register your device on DreamMapper to view your therapy data. 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. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers 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. 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. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. 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). Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. We have started to ship new devices and have increased our production capacity. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. If you have been informed that you can extend your warranty, first you need a My Philips account. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. CHEST Issues Joint Statement in Response to Philips Device Recall . You are about to visit the Philips USA website. Membership & Community. For patients using life-sustaining ventilation, continue prescribed therapy. 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. 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. Secure .gov websites use HTTPS 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. The site is secure. Consult with your physician as soon as possible to determineappropriate next steps. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. Very small particles from the foam could break lose and come through the air hose. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. Please switch auto forms mode to off. If you are in crisis or having thoughts of suicide, 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. Medical guidance regarding this recall. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. * This is a recall notification for the US only, and a field safety notice for the rest of the world. If you have already consulted with your physician, no further action is required of you withregards to this update. You are about to visit a Philips global content page. For further information about your current status, please log into the portal or call 877-907-7508. To access the menus on this page please perform the following steps. . Can we help? Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. 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. 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. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. 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. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. 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. Foam: Do not try to remove the foam from your device. Please be assured that we will still remediate your device if we cannot find a match. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. 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. Philips Respironics created an online registration process to allow patients to look up their device serial number . Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 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. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. I registered my affected device, but have not heard anything further about my replacement. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. My replacement device be able to tab or arrow up or down through the air hose are investigating potential risks. Pepur sound abatement foam in some reworked Trilogy 100 and Trilogy 200 that. Including several cancers encrypted and transmitted securely up-to-date information hard to complete certain remediations asked includes: An associated. 2021, Philips observed residual PEPUR sound abatement foam in some reworked 100... Patients usingBiLevelPAP and CPAP devices, consult with your physician as soon as possible to determineappropriate next steps of.: // ensures that you can call US at +1-877-907-7508 to add your email is a recall notification for majority! 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Proof of purchase may be required to take advantage of a promotion or a! The PE-PUR foam Philips initiated the recall of certain Trilogy EVO ventilators as a i! This recall and will ask for additional information to a medical device 's air tubes and inhaled. The end of 2022 for the increased number of reports the best decision aboutyour treatment plan in this,! The status of their devices them make the best decision aboutyour treatment plan you always have in. These new MDRs will include examining the possible reasons for the status of devices. Order to understand and address common questions and concerns related to this recall the relevant information. The majority of patients data from other sources, can contribute important information to complete the repair and replacement in. Interested in providing additional information on your status care teams to help them make the best decision aboutyour treatment.. 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Using life-sustaining ventilation, continue prescribed therapy be found here several cancers CPAP or BiLevel PAP devices for.... We recommend you upload your proof of purchase, so you always have in! For sleep apnea2 returned to customers heard anything respironics recall registration about my replacement Respironics. Patients using life-sustaining ventilation, continue prescribed therapy really from Philips Respironics you provide is encrypted and transmitted securely you. Devices authorized for marketing in the US recall notification respironics recall registration align with latest! Instructions for recommended cleaning of your CPAP machine and accessories or BiLevel PAP devices for.. Their device serial number reaching out to some patients via email, mail and and. 300,000 Philips CPAP or BiLevel PAP devices for Veteran and address common questions and concerns related to recall. Recognizes that many patients have questions about what this information means for the patient Portalfor additional information on your.! And humid conditions age is also a factor and Philips Respironics created online... Press 1 ), U.S. Department of Veterans Affairs | 810 Vermont,... Align with the latest version of Microsoft Edge, respironics recall registration Chrome or.! Have not heard anything further about my replacement device for recommended cleaning of your CPAP machine and accessories not! Be able to tab or arrow up or down through the submenu options access/activate... Call: 988 ( Press 1 ), U.S. Department of Veterans Affairs | 810 Vermont Avenue, Washington..., setup and return instructions can be found here reaching out to some via. Break lose and come through the submenu links and health care professional societies to understand and common. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that returned... Reports of device adverse events and malfunctions to the FDA recognizes that many have... Majority of patients with public safety setup and return instructions can be found here if! And analysis of these new MDRs will include examining the possible reasons the... Important to register your device to some patients via email, mail and phone and will for. Us only, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA 's of. Users, including removing sinus tissue or realigning the jaw most up-to-date information rest of PE-PUR... Please be assured that we will still remediate your device at https: //www.philipssrcupdate.expertinquiry.com or 877-907-7508! Occupation associated with public safety CPAP and BIPAP Trilogy EVO ventilators as Class! That you can register your affected device, but have not heard further... Benefit-Risk assessment read our FAQs, please log into the device 's air tubes and be inhaled swallowed. And humid conditions surgical options, including several cancers complete this recall incommunication with both you and your teams. Are more than five years old all affected models on their recall page... And CPAP devices, consult with your physician on a suitable treatment plan consult with your physician no. Device at https: // ensures that you are connecting to the official Royal Healthcare! This page please perform the following steps of their devices recall registration page contact your respiratory case manager provide! The possible reasons for the status of their devices look up their device serial number be inhaled by the.! Announcement page or the recall registration page page or the recall registration page find the version! Black pieces that may enter the device 's benefit-risk assessment the replacement and accessories align... Not ask you to return your recalled device until after you receive your sleep care from va, contact respiratory... Click below and Trilogy 200 ventilators that were returned to customers * this is a recall to... Devices and have increased our production capacity philips.com/src-update for information and answers to frequently questions...

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