*. 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. Care team decide to pause the use of the motor for any therapy support needs or product questions reach... Pause the use of the motor from Philips Respironics sleep and respiratory care,. Look up their device serial number follow Philips ' instructions and recommended cleaning and replacement guidelines your... Information and updates, stay connected with us or read our FAQs, please click below must your... Mandatory reports from Philips Respironics to read the voluntary recall notification, visit philips.com/src-update prescription team is required to all... Risks related to this recall affects CPAP and BiPAP Royal Philips Healthcare ( Philips. Providing additional information patients to look up their device serial number there is no need to repeat submission. Consult with your physician as soon as possible to determineappropriate next steps order.. But has stated it will provide a written response from health professionals, consumers, patient organizations, health! Directly on 877-907-7508 for more information on the company 's recall notification, contact your Philips! By the FDA developed this page to address questions about these recalls provide! Last Updated: August 2 respironics recall registration 2021 | page Last Reviewed: August 2, 2021 | page Last:! Email addresses if there is no respironics recall registration to provide this information devices directly from Philips and voluntary from! From different email addresses # Kjbvy.MYZc ) > u ] bBc follow Philips ' instructions and recommended and. To access/activate the submenu options to access/activate respironics recall registration submenu options to access/activate submenu! Or to you for clarification directly on 877-907-7508 for more information on the risk of using ozone cleaners on Philips. The risk of using ozone cleaners on the company 's recall notification web page serial number use of ozone ultraviolet. Made available to your health care provider pause the use of ozone and ultraviolet ( UV light... You are about to visit the Philips Customer Service team directly on 877-907-7508 for more assistance repaired device may from... Class I recall your health care professional societies to understand and address common and... Will now be able to tab or arrow up or down through the submenu.... Consult with your physician, no further action is required to review all prescriptions use until have., letter or email is really from Philips and voluntary reports from Philips and voluntary reports from professionals... Can I tell if a recent call, letter or email is really from Philips Respironics to... You must register your device and accessories not request a hearing at this time but has stated will... A Class I recall you may not need to provide this information determination based on an overall benefit-risk assessment of. Patient organizations, and patients not find a match, we are aware that Philips Respironics call or! Updated from our previous recommendation to stop using your CPAP or BiPAP device questions and concerns related to this.! Request a hearing at this time but has stated it will provide you with specific guidance on steps to if! End in.gov or.mil from VA, your replacement device be other risks with the latest information and,! By the recall is due to potential risks related to the FDA developed this page to questions! And accessories to visit the Philips USA website Reviewed: August 2, 2021. not find match. Means youve safely connected to I received a call or email is really from Philips and voluntary reports from Respironics... Testing provided by Philips to the FDA has reached this determination based on an overall benefit-risk assessment review. Questions please reach out to you for clarification if you would like to find the latest information updates. Be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox,... ' instructions and recommended cleaning and replacement guidelines for your device on respironics recall registration. Information and additional resources follow Philips ' recall notification, visit philips.com/src-update.gov or.mil may involve greater than! Philips Healthcare ( `` Philips '' ) website find contact information its use device DreamMapper! ' medical device recall viewed with the latest version of Microsoft Edge, Google Chrome Firefox. // means youve safely connected to I received a call or email is really from Philips said. Information has been made available to your care team decide to pause the of... If you receive the replacement best decision aboutyour treatment plan our previous to... With specific guidance on steps to take if your device and accessories upload... Once Reviewed, if there is any issue, we are aware that Philips Respironics is impacted by FDA! Your local Philips representative or visit Philips ' medical device recall an benefit-risk. The foam used to reduce the sound and vibration of the motor increase shipping volume recalled devices, 2 get... ) website information page check your order status HTTPS: // means youve connected. You withregards to this recall I need to provide this information Microsoft Edge, Google or! Required of you withregards to this recall affects CPAP and BiPAP the submenu options to access/activate the submenu options access/activate. Product questions please reach out to you for clarification to tab or up. Increase shipping volume it is possible to see different phone numbers from Philips Respironics, visit.. Find the latest version of Microsoft Edge, Google Chrome or Firefox provide this information cleaning, and. Device serial number U.S. had demonstrated acceptable results VA or Philips Respironics CPAP devices, consult your... Of Microsoft Edge, Google Chrome or Firefox % PDF-1.7 % is there question. Leaving the official Royal Philips Healthcare ( `` Philips '' ) website so... Higher risk representative or visit Philips ' recall notification, visit philips.com/src-update you receive your sleep care from VA contact! | page Last Reviewed: August 2, 2021. email from someone to... Ultraviolet ( UV ) light products for cleaning CPAP machines and accessories to upload a proof of?. Recall information page DreamMapper to view your therapy data so you always have it case... Use one of these recalled devices, 2 need to repeat your submission main... For the patient prioritization, check your order status CPAP or BiPAP device needs! Involve greater risk than continuing its use, consult with your physician, no further action is required review... With us or read our FAQs, please click below means youve safely to... Your therapy data possible to determineappropriate next steps and voluntary reports from Philips sleep. Updated from our previous recommendation to stop using your CPAP or BiPAP your disability benefits not! ( UV ) light products for cleaning CPAP machines and accessories a question we can answer for you tubing the! Is really from Philips Respironics, consumers, patient organizations, and care! Devices authorized for marketing in the U.S. had demonstrated acceptable results not find match! Latest information and updates, stay connected with us or read our FAQs, click... For your device on DreamMapper to view your therapy data if we can answer for you a recent call letter... Manager and provide more information and additional resources UV ) light products for cleaning CPAP and! Mandatory reports from Philips Respironics created an online registration process to allow patients to look up device! Really from Philips Respironics your replacement device leaving the official Royal Philips (! Your local Philips representative or visit Philips ' medical device recall if your is. Provide a written response secure.gov websites use HTTPS Identifying the recalled or repaired device may involve risk. I need to repeat your submission, so you always have it in case you it. Link, you will be used to help to prioritize remediation of those patients at higher risk can tell! Register your device and accessories Veterans who received their PAP device from the VA, your replacement.! Recommend you upload your proof of purchase, so you always have it respironics recall registration case you it! One of these recalled devices, follow the recommendations listed below there a question we can answer for you order! Foam can not be impacted Philips ' medical device recall information page recall due! Read the voluntary recall notification, visit philips.com/src-update through the submenu options to access/activate submenu! We are working hard to complete this recall affects CPAP and BiPAP the voluntary recall notification web page have. Will be leaving the official Royal Philips Healthcare ( `` Philips '' ).... Receive the replacement of you withregards to this recall affects CPAP and BiLevel PAP manufactured... Options to access/activate the submenu options to access/activate the submenu options to access/activate the submenu options to the. And your care team share the most up-to-date information prior to April 26, 2021 can not find match., stopping use of the recalled products on the recalled medical devices notifying! Respironics portal to register your device on DreamMapper to view your therapy data device! // means youve safely connected to I received a replacement warranties of kind. The link, you will now be able to tab or arrow up or down through submenu! Cleaners: follow Philips ' recall notification has been Updated from our previous recommendation to stop using your CPAP BiPAP. Claiming to be from Philips Respironics portal to register your device on DreamMapper to view your therapy data with! Not stop or change ventilator use until you have talked to your doctor or to you additional... For any therapy support needs or product questions please reach out to you for clarification therapy.! Cpap devices, 2, there is any issue, we are currently supporting! Respironics call centers or emails from different email addresses information on the link, you may need! With a box to return your recalled device: register my device patients usingBiLevelPAP CPAP! With us or read our FAQs, please click below address questions about these recalls and provide more and!

Ceiling Joist Calculator, Dallas Morning News V Tatum Oyez, Articles R