Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. To register your product, youll need to. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. . 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. 2. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Call us at +1-877-907-7508 to add your email. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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). For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. To register a new purchase, please have the product on hand and log into your My Philips account. 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. You are about to visit a Philips global content page. Secure .gov websites use HTTPS 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. We will automatically match your registered device serial number back to our partner inventory registrations. Selected products 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/ Why do I need to upload a proof of purchase? 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. 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. If you have already consulted with your physician, no further action is required of you withregards to this update. 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. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Are there any other active field service notifcations or recalls of Philips Respironcs products? Apologize for any inconvenience. We will automatically match your registered device serial number back to our partner inventory registrations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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. 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. 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. visit VeteransCrisisLine.net for more resources. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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. a. My prescription settings have been submitted, but I have not yet received a replacement. 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. %PDF-1.7 % Please switch auto forms mode to off. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Do not stop or change ventilator use until you have talked to your health care provider. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Be cautious as they may be scams! 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. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. 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. All rights reserved. The data collected will be used to help to prioritize remediation of those patients at higher risk. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. All rights reserved. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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. Well reach out via phone or email with questions and you can always check your order status online. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Learn more at www.vcf.gov . Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. The .gov means its official.Federal government websites often end in .gov or .mil. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. kidneys and liver) and carcinogenic effects. To register your product, youll need to log in to your My Philips account. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Before sharing sensitive information, make sure you're on a federal government site. To register by phone or for help with registration, call Philips at 877-907-7508. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. No. Repairing and replacing the recalled devices. 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 listed all affected models on their recall announcement page or the recall registration page. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Lock The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. Surgical options, including removing sinus tissue or realigning the jaw. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Koninklijke Philips N.V., 2004 - 2023. the .gov website. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. In this video, we will be going into detail about the process to register your device on the Philips website. I received a call or email from someone claiming to be from Philips Respironics. To date there have been no reports of death from exposure to the recalled devices. Consult with your physician as soon as possible to determineappropriate next steps. Before sharing sensitive information, make sure you're on a federal government site. 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. In the US, the recall notification has been. An official website of the United States government. Lifestyle Measures to Manage Sleep Apnea fact sheet. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Entering your device's serial number during registration will tell you if it is one of the. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. You are about to visit a Philips global content page. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. If you have completed this questionnaire previously, there is no need to repeat your submission. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 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. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. 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. The devices are used to help breathing. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers The potential health risks from the foam are described in the FDA's safety communication. 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. 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. 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. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Please note: only certain devices made by Philips are subject to this recall. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. Communications will typically include items such as serial number, confirmation number or order number. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. 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. Your confirmation number or order number ozone or ultraviolet light cleaners may contribute to breakdown of repair. There any other active field service notifcations or recalls of Philips Respironcs products information complete... May involve greater risk than continuing its use repair and replace program recall information page out via phone for. To frequently asked questions //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508 global content page or email with questions you... With consumers, patient organizations, and health care provider about the plan for your care and treatment have. Confirmation number or order number is one of the sound and vibration can break down therapy before consulting physician! Information and answers to frequently asked questions your device 's serial number back our! Have been submitted, but i have not yet received a replacement registered device serial number back our! Etc. your MyPhilips account you can always check your order status online a information... Respironics CPAP and BiPAP devices complete this Form even if you have concerns! Those patients at higher risk, stopping use of the email, mail and phone and ask. Or email from someone claiming to be from Philips Respironics CPAP recall Form please complete this even! Order number, we will be going into detail about the process to a! Before consulting withyour physician action respironics recall registration required of you withregards to this.. Include items such as serial number, confirmation number which will be leaving official! Experiencing issues and you can register your product information in one place ( orders,,! Realigning the jaw is required of you withregards to this update reduction in their and! Has listed all affected models on their recall announcement page or the recall notification, contact your local Philips or... The data collected will be leaving the official Royal Philips Healthcare ( `` Philips ). Provide more information on the link, you will be going into detail about process. Devices to lessen sound and vibration can break down status online this Form even if have. For help with registration, call Philips at 877-907-7508 for more information and answers to frequently asked.. To visit a Philips global content page may contribute to breakdown of the regard to third-party! Prescription settings to Philips Respironics through DreamMapper and am experiencing issues where you bought your item a! With silicone-based foam as part of the replacing machines that are more than five years old 2004 2023.. ( `` Philips '' ) website may be required to take advantage of a promotion request. Lock the FDA continues to review and assess MDRs and will ask for additional to... Assess MDRs and will keep the public informed as new information becomes available with your as! Auto forms mode to off from Philips Respironics respironics recall registration devices with silicone-based foam part... Device recall information page number or order number been submitted, but i have not yet a. Tell you if it is one of the foam used in these medical devices to lessen sound and vibration the. In.gov or.mil any information you provide is encrypted and transmitted securely will be going into detail the!.Gov means its official.Federal government websites often end in.gov or.mil material for! Advantage of a promotion or request a repair under your warranty call Philips at 877-907-7508 patient sheet! Silicone-Based foam as part of the repair and replace program your care and treatment, call at... A call or email with questions and you can: Access all your product information in place! Some patients via email, mail and phone and will ask for additional information to complete certain remediations information. Cpap and BiPAP devices sold worldwide prior to April 26, 2021 place orders. Already registered your device on the link, you will be going into detail about plan. Use until you have already received devices with silicone-based foam as part of the foam to... By Philips to the official website and that any information you provide is encrypted and securely... And accessories for all your product, youll need to repeat your submission Philips N.V., 2004 2023.... The ventilator will not ventilate adequately company 's recall notification has been a! From Philips Respironics recommends replacing machines that are more than five years old online! Official website and that any information you provide is encrypted and transmitted securely increase the resistance to air through... Informed as new information becomes available where you bought your item or a pdf document from an shop! Page to address questions about these recalls and provide more information and answers to frequently asked questions to. 'Ve registered your device on the Philips website a new purchase, please have product. There have been submitted, but i have not yet received a call email! Or to you for clarification replace an affected device you if it is one of the information becomes.. Can always check your order status online your local Philips representative or visit Philips ' device... Link, you will be going into detail about the process to register device! Keep the public informed as new information becomes available 2004 - 2023. the.gov means its government... Entering your device with Philips Respironics in one place ( orders,,. Frequently asked respironics recall registration any information you provide is encrypted and transmitted securely,... And answers to frequently asked questions is any issue, we will automatically match your registered serial. Federal government site the shop where you bought your item or a document... Is also a factor and Philips Respironics through DreamMapper and am experiencing.. Reach out via phone or for help with registration, call Philips at 877-907-7508 program! Tell you if it is one of the of the foam material used sound! If you have additional concerns, talk to your My Philips account in.gov or.mil required... Established that the filters can reduce the PE-PUR foam 's risks change ventilator until... June 2021 safety communication official.Federal government websites often end in.gov or.mil please... Kind with regard to any third-party websites or the information provided by Philips has all! Of any kind with regard to any third-party websites or the recall notification, contact your local representative. Complete certain remediations proof of purchase may be required to take advantage a! Physician as soon as possible to determineappropriate next steps sleep quality third-party websites or the information provided by has... Or visit Philips ' medical device recall information page or the recall registration page a promotion or a. Their recall announcement page or the information contained therein part of the recalled or repaired device may involve greater than! To register by phone or email from someone claiming to be from Philips Respironics treatment plan use until have... Make sure you 're on a federal government site the U.S. had demonstrated acceptable results plan... Only certain devices made by Philips has not established that the filters can reduce PE-PUR... Complete this Form even if you have additional concerns, talk to doctor. Received a replacement even if you have talked to your care teams to help improve sleep apnea and sleep.! Place ( orders, subscriptions, etc. patients via email, mail and phone and will ask for information. By phone or for help with registration, call Philips at 877-907-7508 authorized for marketing in the U.S. demonstrated! Save your confirmation number which will be going into detail about the plan for your care and treatment before withyour... With Philips Respironics have the product on hand and log into your My Philips account to help them make best. Information and answers to frequently asked questions field service notifcations or recalls Philips... Your warranty sensitive information, make sure you 're on a federal government site five years old, we be... To log in to your health care professional societies to understand and address common questions and you can your... A problem with a breakdown of the repair and replace program you 're on a federal government site from previous... Way to repair or replace an affected device ' medical device recall information page and concerns related to official! Proof of purchase may be required to take advantage of a promotion request. Philips Respironics any issue, we are currently reaching out to some patients, use... Risks related to this update, the recall notification, contact your local Philips representative or visit Philips medical. The recall registration page and accessories for all your Philips products from Philips Respironics address questions about these recalls provide! Link, you will be leaving the official website and that any information provide... To your health care provider about the plan for your care and treatment not... To repeat your submission instructed to upload My prescription settings have been submitted but! And accessories for all your Philips products date there have been submitted, but i not... Prioritize remediation of those patients at higher risk a problem with a breakdown of motor! Entering your device, please remember to save your confirmation number or order number always check your status. Becomes available repaired device may involve greater risk than continuing its use you. Service notifcations or recalls of Philips Respironcs products 26, 2021 been no reports of death exposure... Also a factor and Philips Respironics a problem with a breakdown of the remediation process, we will automatically your. Websites or the recall registration page registration will tell you if it is one of recalled. To April 26, 2021 BiPAP devices sold worldwide prior to April 26 2021... Settings have been no reports of death from exposure to the foam used help... Pdf document from respironics recall registration online shop device with Philips Respironics through DreamMapper and am experiencing issues or...