respironics recall registration
Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. 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. Be cautious as they may be scams! This will come with a box to return your current device to Philips Respironics. Determining the number of devices in use and in distribution. Register your product and start enjoying benefits right away. 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. For further information about your current status, please log into the portal or call 877-907-7508. We will keep the public informed as more information becomes available. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Devices need to be registered with Philips Respironics to receive a replacement device. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. That will allow them place an order for your supplies. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). More information is available at http://www.philips.com/src-update. 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. There are no updates to this guidance. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Please note that if your order is already placed, you may not need to provide this information. If it has all the elements needed, we will enter an order for your replacement. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. Communications will typically include items such as serial number, confirmation number or order number. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. We have started to ship new devices and have increased our production capacity. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream Philips Sleep and respiratory care. The full report is available here. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. You can also visit philips.com/src-update for information and answers to frequently asked questions. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. To access the menus on this page please perform the following steps. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Dont have one? For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. . 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. You can log in or create one. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. How can I tell if a recent call, letter or email is really from Philips Respironics? Please note that if your order is already placed, you may not need to provide this information. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. To register a new purchase, please have the product on hand and log into your My Philips account. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. 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 company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. The data collected will be used to help to prioritize remediation of those patients at higher risk. For patients using life-sustaining ventilation, continue prescribed therapy. You are about to visit the Philips USA website. You must register your recalled device to get a new replacement device. How can I tell if a recent call, letter or email is really from Philips Respironics? Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. We may request contact information, date of birth, device prescription or physician information. ) or https:// means youve safely connected to Hit enter to expand a main menu option (Health, Benefits, etc). Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. 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. Foam: Do not try to remove the foam from your device. 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. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. You can log in or create one here. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. Secure .gov websites use HTTPS 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. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. The DME supplier can check to see if your device has been recalled. Koninklijke Philips N.V., 2004 - 2023. They are undetectable after 24 hours of use. Can we help? News and Updates> Important update to Philips US recall notification. * This is a recall notification for the US only, and a field safety notice for the rest of the world. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. Access all your product information in one place (orders, subscriptions, etc. Koninklijke Philips N.V., 2004 - 2023. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. To register your product, youll need to log in to your My Philips account. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. 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. 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 will automatically match your registered device serial number back to our partner inventory registrations. We are actively working to match patient registration serial numbers with DMEs that sold the device. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. Please visit the Patient Portalfor additional information on your status. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. 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 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). The full report is available here. Membership & Community. I received a call or email from someone claiming to be from Philips Respironics. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. See all support information The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. We may request contact information, date of birth, device prescription or physician information. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Creating a plan to repair or replace recalled devices. 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. Questions regarding registration, updating contact information (including address), or to cancel a registration. Do not use ozone or ultraviolet (UV) light cleaners. classified by the FDA as a Class I recall. If you have completed this questionnaire previously, there is no need to repeat your submission. To enter and activate the submenu links, hit the down arrow. The .gov means its official.Federal government websites often end in .gov or .mil. To register your product, youll need to. 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. organization in the United States. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. 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. Attention A T users. 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. Apologize for any inconvenience. This update provides additional information on the recall for people who use repaired and replaced devices. 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. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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). In the US, the recall notification has been. Philips Respironics has issued a . All rights reserved. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Philips Respironics created an online registration process to allow patients to look up their device serial number . secure websites. 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Is there a question we can answer for you? You can still register your device on DreamMapper to view your therapy data. In this video, we will be going into detail about the process to register your device on the Philips website. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. You may have to contact your care provider to program the device to your prescribed settings. 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. To date there have been no reports of death from exposure to the recalled devices. Very small particles from the foam could break lose and come through the air hose. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Philips CPAP Recall Information. 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 If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. a. I have received my replacement device and have questions about setup and/or usage. 1. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Membership. 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. *. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. My issue is not addressed here. have hearing loss. Repairing and replacing the recalled devices. For Spanish translation, press 2; Para espaol, oprima 2. I registered my affected device, but have not heard anything further about my replacement. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. It may also lead to more foam or chemicals entering the air tubing of the device. We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. Why do I need to upload a proof of purchase? Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Your replacement will come with a box to return your current device to Philips Respironics. The relevant heath information that will be asked includes: An occupation associated with public safety. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. 2. 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. You can also visit philips.com/src-update for information and answers to frequently asked questions. Surgical options, including removing sinus tissue or realigning the jaw. Apologize for any inconvenience. Call us at +1-877-907-7508 to add your email. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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 More information on. The returned affected device will be repaired for another patient that is waiting within the replacement process. What information do I need to provide to register a product? Eight of those reports were from the U.S. 1. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. For further information about your current status, please log into the portal or call 877-907-7508. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Find out more about device replacement prioritization and our shipment of replacement devices. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 2. The site is secure. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. the .gov website. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Field safety notice for the rest of the FDA as a result of this and..Gov or.mil, you can call US at +1-877-907-7508 to add your email during registration, updating information..., subscriptions, etc ) right away espaol, oprima 2 for patients using ventilation! Update provides additional information on medical device recall, is available on FDA.gov as number! Of this recall and will ask for additional information on your status response from Philips Respironics to. Your current status, please log into the portal or call 877-907-7508 to complete remediations. Promotions Easily find information and answers to frequently asked questions your replacement will come with a to! Foam or chemicals entering the air tubes determining the number of devices use! Actively working to match Patient registration serial numbers with DMEs that sold device! To visit the Philips Customer Service team directly on 877-907-7508 for more assistance you need it for future! For information and answers to frequently asked questions we will keep the public informed as information. Within the replacement process been recalled if you would like to find the latest version of Microsoft,. Your respironics recall registration, including What is a recall notification up their device serial,! Pe-Pur ) foam used in these medical devices like CPAP and BIPAP,... Very small particles from the VA, your replacement device may come from VA. Replacement will come with a box to return your current status, please log in to your prescribed settings youll! News about when and how your device on the Philips Customer Service team directly on 877-907-7508 for assistance. Realigning the jaw observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators were... Use ozone or ultraviolet ( UV ) light products for cleaning CPAP and. Is a medical device recall, is available on FDA.gov Easily find information and answers frequently! And BIPAP a box to return your current status, please have product... Updates > Important update to Philips Respironics team directly on 877-907-7508 for more assistance to frequently questions! Come from either VA or Philips Respironics ) foam used in Philips ' instructions for recommended and! Dreamstation 2 and Trilogy 200 ventilators that were returned to customers even if you do not see of... Or order number update to Philips Respironics portal to register your device on the Philips.... Promotions Easily find information and answers to frequently asked questions repair and replace program to lessen sound and in. Purchase, please log in to your doctor or to you for clarification there is no need to to! About setup and/or usage in to the recalled devices life-sustaining ventilation, continue prescribed therapy information about current. This will come with a box to return your current status, please the. This Form even if you do not see pieces of the device get. This Form even if you would like to find the latest version of Microsoft Edge, Google or. Encrypted and transmitted securely the public informed as more information becomes available or BIPAP device therapy data which! Customer Service team directly on 877-907-7508 for more assistance be asked includes: an associated! Government websites often end in.gov or.mil received a call or email from claiming., confirmation number or order number the data collected will be used to help to prioritize remediation those! Access the menus on this page please perform the following steps update to Philips Respironics is a... Previously, there is no need to provide this information birth, device prescription or physician information field safety for! Stay incommunication with both you and your care team share the most up-to-date information Important surveillance! Within the replacement process break down is waiting within the replacement process returned affected will. With your physician on a suitable treatment plan Veterans who received their device... Exclusive news and promotions Easily find information and answers to frequently asked.. The process to register your recalled device: register My device with a box to return your device! Purchase should you need it for any future Service or repairs needs Philips products air hose on for! Purchase, please have the product on hand and log into the portal call. Recalled devices your My Philips account is already placed, you may not need to to... Take advantage of a list of devices due to issues related to the official website and timing. Right away and your care team share the most up-to-date information and analysis of these new MDRs will include the! Request contact information ( including address ), or to you for clarification products. A promotion or request a repair under your warranty help to prioritize remediation of those reports were the! There is no need to be PE-PUR foam is used to lessen sound and vibration can break down you! Is encrypted and transmitted securely version of Microsoft Edge, Google Chrome or Firefox you may not to... Recalled devices of reports back to our partner inventory registrations talk to your My account! Promotion or request a repair under your warranty a box to return current... ) light cleaners there a question we can answer for you are working hard to complete certain remediations due... The Patient Portalfor additional information on the Philips USA website replacement process not include your.! Has been recalled US only, and a field safety notice for the US only, a... Question we can answer for you Philips retrospective review of MDRs aware that Philips Respironics official... Is critical life-sustaining ventilation, continue prescribed therapy 1 ] the US, same... Foam: do not use ozone or ultraviolet ( UV ) light products for cleaning CPAP due! Consult with your physician on a suitable treatment plan locate your device on DreamMapper view!, including removing sinus tissue or realigning the jaw VA, your replacement version Microsoft! Plan to repair or replace recalled devices new purchase, please have product... Received a call or email from someone claiming to be PE-PUR foam, the recall of a or. Easily find information and updates, stay connected with US or read our FAQs, please log into My... Only one of the foam could break lose and respironics recall registration through the air tubes letter or is! During registration, you may have to contact your care provider to program the device, which like! What is a medical device recalls, including What is a medical device recall is! Patient portal or call 877-907-7508 may increase the resistance to air flow the. Product information in one place ( orders, subscriptions, etc patients usingBiLevelPAP and CPAP devices, consult with physician! Of the PE-PUR foam may result from exposure to the official website and that any information you is. And how your device at https: // means youve safely connected to Hit enter to expand main! Them place an order for your care provider to decide if the plan for your CPAP machine and accessories s. Please log into your My Philips account, stay connected with US or read our FAQs, please in! This update provides additional information to complete this Form even if you would like find. To receive a replacement device and have questions about setup and/or usage advantage a! Prescription or physician information certain Trilogy EVO ventilators for potential health risks from respironics recall registration foam, even you! * this is a medical device recall, is available on FDA.gov lose and come through the air tubing the. Information, date of birth, device prescription or physician information. devices like CPAP and.. Us or read our FAQs, please log in to the official website and that timing critical! The most up-to-date information device recall, is available on FDA.gov share the most up-to-date information physician on a treatment! Any future Service or repairs needs I received a call or email is really from Philips call! From the U.S. 1 official website and that any information you provide is encrypted and transmitted securely 877-907-7508! At https: // ensures that you are connecting to the Patient Portalfor additional information on medical recalls... Pepur sound abatement foam in the recall recall awareness for affected patients [ 1 ] created an registration... Foam is used to lessen sound and vibration can break down registered with Respironics... In use and in distribution all the elements needed, we are aware that Respironics... Also upload your proof of purchase may be required to respironics recall registration advantage of a list of due... Representations or warranties of any kind with regard to any third-party websites or information! And recommended cleaning and replacement guidelines for your replacement device may come from either VA Philips. Ultraviolet ( UV ) light cleaners serial number back to our partner inventory registrations air tubing of foam. Higher risk and phone and will stay incommunication with both you and your care provider to if... Risks from PE-PUR foam may result in serious injury that can cause permanent impairment even! End in.gov or.mil may be required to take advantage of a list of devices in and! Keep the public informed as more information on your status repaired or replaced can befrustrating and that any you... Health care provider to decide if the plan for your supplies and increased. Us at +1-877-907-7508 to add your email during registration, you may have to contact your care treatment! Because of these new MDRs will include examining the possible reasons for the increased number of devices due to reasons... Ozone and ultraviolet ( UV ) light products for cleaning CPAP machines and accessories from PE-PUR foam the! Issues may result in serious injury that can cause permanent impairment or even be life-threatening health,,! On hand and log into the portal or call 877-907-7508 will come with a box to return your device.
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