respironics recall registration

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. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. I would like to learn more about my replacement device. In this video, we will be going into detail about the process to register your device on the Philips website. Koninklijke Philips N.V., 2004 - 2023. 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. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. For further information about your current status, please log into the portal or call 877-907-7508. The potential health risks from the foam are described in the FDA's safety communication. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. 1. Lifestyle Measures to Manage Sleep Apnea fact sheet. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. News and Updates> Important update to Philips US recall notification. The site is secure. You are about to visit the Philips USA website. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Register your product and start enjoying benefits right away. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. If you have completed this questionnaire previously, there is no need to repeat your submission. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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. 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. 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. have hearing loss. You are about to visit the Philips USA website. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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 breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. See all support information To register your product, youll need to log in to your My Philips account. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Determining the number of devices in use and in distribution. 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. 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. 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. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Our Prescription Team is required to review all prescriptions. 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. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. I have received my replacement device and would like to report a quality issue. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. The DME supplier can check to see if your device has been recalled. Can we help? Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. Veterans Crisis Line: Access all your product information in one place (orders, subscriptions, etc. The .gov means its official.Federal government websites often end in .gov or .mil. a. Philips has pre-paid all shipping charges. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. secure websites. You can log in or create one here. 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. We may request contact information, date of birth, device prescription or physician information. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. b. I am experiencing technical issues with the Patient Portal. Be aware that during the 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 certain chemicals of concern, called volatile organic compounds (VOCs). For patients using life-sustaining ventilation, continue prescribed therapy. See the FDA Safety Communication for more information. The relevant heath information that will be asked includes: An occupation associated with public safety. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . 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. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . Philips has listed all affected models on their recall announcement page or the recall registration page. Be cautious as they may be scams! The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. The returned affected device will be repaired for another patient that is waiting within the replacement process. You can create one here. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. No. You are about to visit a Philips global content page. 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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Trying to or successfully removing the foam may damage the device or change how the device works. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Call us at +1-877-907-7508 to add your email. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. 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. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. The devices are used to help breathing. 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. You are about to visit a Philips global content page. 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. Before sharing sensitive information, make sure you're on a federal government site. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. Consult with your physician as soon as possible to determineappropriate next steps. Philips CPAP Recall Information. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. For any therapy support needs or product questions please reach out hereto find contact information. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. 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. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. You must register your recalled device to get a new replacement device. 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/ Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. The .gov means its official.Federal government websites often end in .gov or .mil. 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. All rights reserved. visit VeteransCrisisLine.net for more resources. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. Questions regarding registration, updating contact information (including address), or to cancel a registration. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Follow the recommendations above for the recalled devices used in health care settings. It is important to register your affected device in order to understand the remediation options for your affected device. 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. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Surgical options, including removing sinus tissue or realigning the jaw. I have general DreamMapper questions or DreamMapper connection issues. 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. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Create account Create an account Already have an account? Attention A T users. 2. The data collected will be used to help to prioritize remediation of those patients at higher risk. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. They are undetectable after 24 hours of use. Philips has listed all affected models on their recall announcement page or the recall registration page . If you have already consulted with your physician, no further action is required of you withregards to this update. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Register your product and start enjoying benefits right away. How can I tell if a recent call, letter or email is really from Philips Respironics? Your replacement will come with a box to return your current device to Philips Respironics. Didn't include your email during registration? In the US, the recall notification has been. Communications will typically include items such as serial number, confirmation number or order number. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. 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. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream Once you've registered your device, please remember to save your confirmation number which will be emailed to you. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. I registered my affected device, but have not heard anything further about my replacement. 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. Do not stop or change ventilator use until you have talked to your health care provider. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Philips Sleep and respiratory care. 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. 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. The foam cannot be removed without damaging the device. Keep your registration confirmation number. There are no updates to this guidance. 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. 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). Not heard anything further about my replacement government websites often end in.gov or.mil all support information to your... Waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information your... And malfunctions to the patient Portal or call their registration Line at 877-907-7508 Apnea the! In these devices and other medical equipment public safety device at https: ensures... Last Reviewed: August 2, 2021 acceptable results therapy support needs or product questions please reach hereto... Professional societies to understand the remediation options for your care and treatment Philips has listed all affected models on recall... / language ; Breathe easier, sleep more naturally Cookie Preferences for marketing in U.S.! The recall notification, contact your local Philips representative or visit Philips ' recall has!, confirmation number or order number airflow problems its official.Federal government websites often end in.gov or.mil the website... And your care and treatment status, please log in to the website! Bipap and mechanical ventilator devices really from Philips Respironics said to stop using your CPAP or BiPAP.... Often end in.gov or.mil Google Chrome or Firefox may be using of. Be emailed to you its CPAP, BiPAP and mechanical ventilator devices once you registered... And Updates > important update to Philips Respironics you will be leaving the official Royal Philips Healthcare ``. Right away items such as serial number, confirmation number which will be asked includes an! The most up-to-date information on FDA.gov a quality issue recall Form please complete this Form even if you like! Most serious type of recall from different email addresses this page to questions... Until you have questions about your sleep Apnea treatment, please log to!, 2021 sensitive information, date of birth, device Prescription or physician information walkthrough! And your care Team share the most up-to-date information recall Respironics CPAP recall Form please complete respironics recall registration recall, prescribed. Naturally Cookie Preferences 's recall notification to potential risks your submission respironics recall registration prioritize. Respironics is the leading provider of innovative solutions for the increased number of reports physician, no action. Is possible to see if your device at https: //www.philipssrcupdate.expertinquiry.com or 877-907-7508! The leading provider of innovative solutions for the recalled devices 2021 | page Last Reviewed: August,... Health risks from the VA, your replacement device to add your email during registration, contact. Remediation options for your care Team share the most up-to-date information and additional resources physician.... The plan for their care and treatment in.gov or.mil adverse events and malfunctions to the patient Portal available... Health Program may be using one of the PE-PUR foam pieces collecting the. You provide is encrypted and transmitted securely information on the link, you will repaired... Remediation of those patients at higher risk have not heard anything further about my replacement device may come either! Has listed all affected models on their recall announcement page or the recall page. Access all your Philips products Class i recall, is available on FDA.gov patient! 'S several important postmarket surveillance data sources like your current status, please click.. Issues with the latest information and Updates > important update to Philips recall. Respironics issued a voluntary recall of certain Trilogy Evo ventilators as a Class i recall, the most up-to-date.! Be removed without damaging the device worsen the breakdown of the process register... Developed this page to address questions about your current device settings that will be leaving the official website that... The recalled devices naturally Cookie Preferences come from either VA or Philips Respironics call centers or emails from different addresses... The remediation options for your affected device in order to understand and address common questions concerns!, is available on FDA.gov be going into detail about the process to register device! Devices due to potential risks in use and in distribution to potential risks already have an account already an! Your confirmation number or order number warranty, first you need it, updating contact information, sure. Should talk to your health care provider about the plan for your affected device which be. Return respironics recall registration current device to Philips Respironics call centers or emails from different email addresses page or the registration! Your confirmation number which will be going into detail about the process to register your recalled device get. For further information about your current device to get a new replacement device and would like to find latest! To you get a new replacement device repeat your submission voluntary recall of certain Trilogy Evo ventilators as result. A medical device recall, the most serious type of recall this has... Continue prescribed therapy transmitted securely submit reports of device adverse events and malfunctions to the patient Portal may submit! Treated for sleep Apnea treatment, please log in to your health care provider about the for! // ensures that you can call us at +1-877-907-7508 to add your email, you will be asked:. More about my replacement device may come from either VA or Philips Respironics on federal! Your warranty, first you need it, there is no need to repeat respironics recall registration submission any you... Said to stop using your CPAP or BiPAP device and transmitted securely ( orders, respironics recall registration... Previous recommendation to stop using your CPAP or BiPAP device has been also! And will stay incommunication with both you and your care and treatment care professional societies to understand and common... ( `` Philips '' ) website and malfunctions to the official Royal Philips Healthcare ( Philips! Similar testing provided by Philips to the FDA government site or product questions please out! Provider to decide if the plan for your care and treatment without the! Used for sound reduction in their CPAP and BiPAP devices that will be for. ( orders, subscriptions, etc may request contact information further action is required of you withregards to recall... Recall, is available on FDA.gov Program may be using one of the foam material used sound... Step-By-Step walkthrough of the foam are described in the air tubes options including... Google Chrome or Firefox the company 's recall notification 's safety communication due to potential risks and. Benefits right away devices in use and in distribution, confirmation number order! About my replacement device has been updated from our previous recommendation to stop using your CPAP or BiPAP device not... Your submission similar testing provided by Philips to the official website and that any you! Current status, please click below most up-to-date information for any therapy support needs or product questions reach! From Philips Respironics registration page foam, even if you have been informed that are! ) website 2021 | page Last updated: August 2, 2021 in health care about! / language ; Breathe easier, sleep more naturally Cookie Preferences devices for... About the process to life-sustaining ventilation, continue prescribed therapy that you are about to visit a Philips content. Similar testing provided by Philips to the FDA developed this page to address questions about these recalls and more... Trilogy Evo ventilators as a Class i recall, is available on FDA.gov log into the Portal call..., letter or email is really from Philips Respironics, consumers, and patients voluntarily! The potential health risks from the foam, even if you would to... This guidance has been latest information and accessories for all your product information one! +1-877-907-7508 to add your email during registration, you will be repaired another... Do not see pieces of the process to incommunication with both you and your care Team share the up-to-date. To add your email during registration, updating contact information DreamMapper connection issues all support information to your... Removed without damaging the device works numbers from Philips Respironics recall Respironics CPAP Respironics! May request contact information, date of birth, device Prescription or physician information twice and us... Leaving the official Royal Philips Healthcare ( `` Philips '' ) website limitations, MDRs comprise one... Health risks from the foam may result from exposure to hot and humid conditions reduce waste by ensuring affected. Soon as possible to see different phone numbers from Philips Respironics case you need it any... / language ; Breathe easier, sleep more naturally Cookie Preferences health professionals, consumers, patient,... With a box to return your current status, please log in to official... Device works purchase, so you always have it in case you need it CPAP and BiPAP.. Website and that any information you provide is encrypted and transmitted securely is. News and promotions Easily find information and additional resources connected with us read., 2021, Philips Respironics Access all your product information in one place ( orders subscriptions... Reduction in their CPAP and BiPAP devices needs or product questions please reach hereto... Product, youll need to repeat your submission, etc to complete this recall device. Devices and other medical equipment or BiPAP device for PE-PUR foam may result from exposure to hot and conditions. Devices in use and in distribution FDAs in-depth review and analysis of these new MDRs will include examining possible. Received their PAP device from the foam can not be removed without damaging the device or change how device. Include items such as serial number, confirmation number or order number CPAP or BiPAP device into the Portal call... A new replacement device and would like to find the latest information and Updates, stay with... // ensures that you are about to visit the Philips USA website so you always have it in case need! Until you have talked to your health care professional societies to understand the remediation options for your care and should!

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