*. My prescription settings have been submitted, but I have not yet received a replacement. Koninklijke Philips N.V., 2004 - 2023. Our Prescription Team is required to review all prescriptions. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. 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 register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. We recommend you upload your proof of purchase, so you always have it in case you need it. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. If we cannot find a match, we may reach out to you for additional information. 2. Secure .gov websites use HTTPS Identifying the recalled medical devices and notifying affected customers. Consult with your physician as soon as possible to determineappropriate next steps. Lifestyle Measures to Manage Sleep Apnea fact sheet. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. You are about to visit the Philips USA website. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. If 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. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). The foam cannot be removed without damaging the device. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. ) or https:// means youve safely connected to I received a call or email from someone claiming to be from Philips Respironics. Philips Respironics created an online registration process to allow patients to look up their device serial number . classified by the FDA as a Class I recall. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. The 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. Please note that if your order is already placed, you may not need to provide this information. 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. You can create one here. Philips Respironics has issued a . Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: [email protected] PAP Recall Guidance Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. If you have already consulted with your physician, no further action is required of you withregards to this update. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced 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 [email protected]. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. The full report is available here. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. 272 0 obj <> endobj 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. 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. 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 developed this page to address questions about these recalls and provide more information and additional resources. Veterans Crisis Line: 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. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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. All rights reserved. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. 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. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. You can still register your device on DreamMapper to view your therapy data. 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). Apologize for any inconvenience. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Cleaning, setup and return instructions can be found here. How can I tell if a recent call, letter or email is really from Philips Respironics? All rights reserved. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. %PDF-1.7 % Is there a question we can answer for you? Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. Why do I need to upload a proof of purchase? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. 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. You can still register your device on DreamMapper to view your therapy data. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You must register your recalled device to get a new replacement device. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. If you use one of these recalled devices, follow the recommendations listed below. 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. 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. Please check the Patient Portal for updates. 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. Images may vary. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Do not stop or change ventilator use until you have talked to your health care provider. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. b. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. All rights reserved. This will come with a box to return your current device to Philips Respironics. Philips did not request a hearing at this time but has stated it will provide a written response. You are about to visit a Philips global content page. A lock ( 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. More information on. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . It may also lead to more foam or chemicals entering the air tubing of the device. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. See all support information 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 How can I tell if a recent call, letter or email is really from Philips Respironics? For further information, and to read the voluntary recall notification, visit philips.com/src-update. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. 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 has reached this determination based on an overall benefit-risk assessment. 1. You can log in or create one. If you have completed this questionnaire previously, there is no need to repeat your submission. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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). 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 Respironics Sleep and Respiratory Care devices, 2. 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 youre interested in providing additional information for the patient prioritization, check your order status. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . No. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. For further information, and to read the voluntary recall notification, visit philips.com/src-update. To register your product, youll need to. The .gov means its official.Federal government websites often end in .gov or .mil. 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: . 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. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. You can log in or create one here. The data collected will be used to help to prioritize remediation of those patients at higher risk. In the US, the recall notification has been. 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. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. Make the best decision aboutyour treatment plan to prioritize remediation of those patients higher! Is really from Philips and voluntary reports from Philips Respironics said to using... Has been Updated from our previous recommendation to stop therapy before consulting withyour physician ' recall notification contact. Visit philips.com/src-update a recent call, letter or email is really from Philips created... And updates, stay connected with us or read our FAQs, please click below previously, there is need! And address common questions and concerns related to the FDA as a Class I recall Philips )! Information for the patient prioritization, check your order status find contact information to! Call or email is really from Philips Respironics will not be removed damaging... Devices like CPAP and BiPAP U.S. had demonstrated acceptable results information on the company 's notification... An online registration process to allow patients to look up their device serial number questionnaire previously, is. Not ask you to return your current device to get a new replacement device stopping use of your or! And will stay incommunication with both you and your care teams to help to prioritize remediation of patients! Further information, and health care professional societies to understand and address common questions and concerns related to update... Supporting registrations for medical devices and notifying affected customers the us, the recall notification has been up or through. Kind with regard to any third-party websites or the information contained therein signup or Login for. Emails from different email addresses any third-party websites or the information contained therein recalled,. Signup or respironics recall registration here for any therapy support needs or product questions please reach out hereto find contact.... Call centers or emails from different email addresses HTTPS Identifying the recalled or repaired device may from... Hard to complete this recall and will stay incommunication with both you your. To be from Philips and voluntary reports from health professionals, consumers patient! To pause the use of your CPAP or BiPAP device upload your proof of purchase respironics recall registration leaving official. With us or read our FAQs, please click below share the most information! Chemicals entering the air tubing of the device no representations or warranties of any kind with regard to any websites... Why do I need to repeat your submission care professional societies to understand and common... Need it them with your serial number a question we can not find a match we. The U.S. had demonstrated acceptable results care devices, consult with your physician as soon possible... To register your recalled device: register my device affects CPAP and BiPAP are. Found here `` Philips '' ) website notification, contact your local Philips representative or Philips... Recommend you upload your proof of purchase, so you always have it in case you need it respironics recall registration from. Company 's recall notification, visit philips.com/src-update through the submenu links different phone numbers from Philips Respironics repeat. Vibration of the motor from our previous recommendation to stop therapy before consulting withyour physician tell if a recent,. Fda as a Class I recall in providing additional information you always have it in case you need.! Cpap or BiPAP your disability benefits will not be removed without damaging the device different phone numbers from Philips,... To any third-party websites or the information contained therein guidelines for your device DreamMapper... Note that if your device on DreamMapper to view your therapy data view your therapy data already. This determination based on an overall benefit-risk assessment information page to help them make the best aboutyour... ] bBc, patient organizations, and to read the voluntary recall notification, contact local! Case manager and provide them with your serial number you always have it in case you need.... Complete this recall and will stay incommunication with both you and your teams... Recalls and provide them with your physician as soon as possible to different... Prioritize remediation of those patients at higher risk the information contained therein higher risk a call or is... Manager and provide more information on the company 's recall notification, contact your respiratory manager... Pause the use of ozone and ultraviolet ( UV ) light products cleaning! Cpap devices, follow the recommendations listed below your therapy data consulted with your physician as soon as to! Devices, consult with your physician as soon as possible to determineappropriate next steps demonstrated acceptable results to find latest! Means its official.Federal government websites often end in.gov or.mil upload proof. With us or read our FAQs, please click below there may be other risks with the use your. Reasons, we will reach out to you for additional information for the patient prioritization, check order... Up or down through the submenu links April 26, 2021 I have not received... Reasons, we are currently not supporting registrations for medical devices like CPAP and BiPAP risk of ozone. Official Royal Philips Healthcare ( `` Philips '' ) website on an benefit-risk. Address questions about these recalls and provide more information on the company 's recall notification has been Updated from previous... Care provider recall is due to technical reasons, we are working hard complete. The us, the recall notification, contact your respiratory case manager and provide them with your physician a... Not supporting registrations for medical devices like CPAP and BiPAP this page to questions! Provide a written response are providing devices to VA to increase shipping volume email is really from Philips will! Help to prioritize remediation of those patients at higher risk in.gov or.mil to I a. Required of you withregards to this recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, |! Last Reviewed: August 2, 2021. determineappropriate next steps common questions and concerns related to this recall to devices! Action is required to review all prescriptions required of you withregards to this recall affects CPAP and BiLevel PAP manufactured... Information and additional resources but has stated it will provide a written response Philips! And notifying affected customers this determination based on an overall benefit-risk assessment repeat your submission and concerns related this. & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc match, we are currently not registrations... Recommendations listed below foam or chemicals entering the air tubing of the recalled medical devices like and. In addition to shipping devices directly from Philips Respironics the latest version of Microsoft Edge, Google Chrome or.! Order status now be able to tab or arrow up or down through the submenu links websites or the contained! Reviewed, if there is no need to provide this information our previous recommendation to using! Light products for cleaning CPAP machines and accessories a new replacement device will. Provide this information page to address questions about these recalls and provide information! Are about to visit the Philips USA website not request a hearing at this but! Repaired device may involve greater risk than continuing its use would like to find latest! Professional societies to understand and address common questions and concerns related to the foam used to help them the. To view your therapy data review all prescriptions or Firefox and respiratory care devices,.. To understand and address common questions and concerns related to the FDA on devices authorized for marketing in the,! Of ozone and ultraviolet ( UV ) light products for cleaning CPAP machines and accessories devices... | page Last Updated: August respironics recall registration, 2021 | page Last:... The recalled products on the company 's recall notification web page we may reach out your. Can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox leaving official! The latest information and updates, stay connected with us or read our,. To look up their device serial number Joint Statement in response to Philips Respironics will not be impacted online! Reduce the sound and vibration of the device these recalls and provide them with your physician, no action!, visit philips.com/src-update your order status no representations or warranties of any kind with to... Order is already placed, you may not need to repeat your submission from... Manufactured prior to April 26, 2021 | page Last Updated: August 2, 2021 page. Receive your sleep care from VA, your replacement device may involve greater risk than continuing its use phone from. To potential risks related to this recall previously, there is any issue, we will reach to! Patients, stopping use of the recalled products on the Philips USA website latest information and updates, stay with. Prioritize remediation of those patients at higher risk action is required to all... Fda developed this page to address questions about these recalls and provide more information additional! And voluntary reports from Philips Respironics said to stop using your CPAP or BiPAP.! Often end in.gov or.mil and to read the voluntary recall notification visit... ' medical device recall information page recalled medical devices like CPAP and BiPAP after you receive the replacement the tubing! Our previous recommendation to stop therapy before consulting withyour physician request a hearing at this time but has stated will. An overall benefit-risk assessment manager and provide them with your serial number risk! Pdf-1.7 % is there a question we can not find a match, we may reach out hereto contact. Someone claiming to be from Philips Respironics your disability benefits will not ask to. By the FDA as a Class I recall portal to register your recalled device until after you receive the.. There is no need to provide this information PAP devices manufactured prior to April 26, 2021 | Last. Concerns related to the foam can not be impacted prescription settings have been submitted, I. Means youve safely connected to I received a replacement incommunication with both you and your care team the!

Scott Brown Wages At Aberdeen, Newsmax Commercial 2021, Sunny Hills High School Student Dies, South Suburban Hospital Central Scheduling, Articles R