You are about to visit a Philips global content page. 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. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. By returning your original device, you can help other patients. 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. My prescription settings have been submitted, but I have not yet received a replacement. Philips Respironics has issued a . 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. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. In the US, the recall notification has been classified by the FDA as a Class I recall. 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: RecallPrescriptions@philips.com PAP Recall Guidance I registered my affected device, but have not heard anything further about my replacement. Keep your registration confirmation number. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. There are currently no items in your shopping cart. 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. To register a new purchase, please have the product on hand and log into your My Philips account. 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. Please note that if your order is already placed, you may not need to provide this information. 2. I need to change my registration information. Do not use ozone or ultraviolet (UV) light cleaners. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For patients using life-sustaining ventilation, continue prescribed therapy. To register your product, youll need to. 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. 22 Questions Please call us so we can get your question routed to the team that can best assist you with your issue. 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 focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The relevant heath information that will be asked includes: An occupation associated with public safety. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. 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. To register your product, youll need to log in to your My Philips account. 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. More information on. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. All rights reserved. Determining the number of devices in use and in distribution. Call us at +1-877-907-7508 to add your email. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). 1. To register your device and check if your machine is included in the recall: Locate the serial number of your device. * This is a recall notification for the US only, and a field safety notice for the rest of the world. 1. 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. I have received my replacement device and have questions about setup and/or usage. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. Follow the recommendations above for the recalled devices used in health care settings. 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. Please be assured that we will still remediate your device if we cannot find a match. Philips Respironics continues to monitor recall awareness for affected patients [1]. 2. Please switch auto forms mode to off. Call us at +1-877-907-7508 to add your email. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Access all your product information in one place (orders, subscriptions, etc. have hearing loss. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. If you do not find your device on the list, then it has not been recalled and you should continue to use it. We will automatically match your registered device serial number back to our partner inventory registrations. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. This will come with a box to return your current device to Philips Respironics. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Use another similar device that is not a part of this recall. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. If you have already consulted with your physician, no further action is required of you withregards to this update. Surgical options, including removing sinus tissue or realigning the jaw. Hit enter to expand a main menu option (Health, Benefits, etc). Please note: only certain devices made by Philips are subject to this recall. 2. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. The FDA developed this page to address questions about these recalls and provide more information and additional resources. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. 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. I have general DreamMapper questions or DreamMapper connection issues. Philips Respironics created an online registration process to allow patients to look up their device serial number . 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. Consult with your physician as soon as possible to determineappropriate next steps. 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. If you have been informed that you can extend your warranty, first you need a My Philips account. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Why do I need to upload a proof of purchase? Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. For more information of the potential health risks identified, see the FDA Safety Communication. 2. I have received my replacement device and would like to report a quality issue. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. You can log in or create one here. Didn't include your email during registration? Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Register your product and start enjoying benefits right away. You can create one here. You may have to contact your care provider to program the device to your prescribed settings. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. Philips did not request a hearing at this time but has stated it will provide a written response. The potential health risks from the foam are described in the FDA's safety communication. 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. To enter and activate the submenu links, hit the down arrow. UPDATE - February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. 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. 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. 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. The DME supplier can check to see if your device has been recalled. They are undetectable after 24 hours of use. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. In the US, the recall notification has been classified by the FDA as a Class I recall. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. 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 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. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. If you have already consulted with your physician, no further action is required of you withregards to this update. 3. See all support information Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. We recommend you upload your proof of purchase, so you always have it in case you need it. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Log in Koninklijke Philips N.V., 2004 - 2023. Three types of devices have been recalled: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. a. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Images may vary. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 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). 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 . *. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. Veterans Crisis Line: The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. We are investigating potential injury risks to users, including several cancers. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. visit VeteransCrisisLine.net for more resources. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. 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. Questions regarding registration, updating contact information (including address), or to cancel a registration. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. 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. You can log in or create one. Selected products For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. For any therapy support needs or product questions please reach out hereto find contact information. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) How can I register my product for an extended warranty? Find out more about device replacement prioritization and our shipment of replacement devices. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). organization in the United States. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. CHEST Issues Joint Statement in Response to Philips Device Recall . The FDA's evaluation of the information provided by Philips is ongoing. 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. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. Looking for U.S. government information and services? The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. The data collected will be used to help to prioritize remediation of those patients at higher risk. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Please call our registration line or visit our registration website. If you use one of these recalled devices, follow the recommendations listed below. 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. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. Official websites use .gov 303 0 obj <>stream You can still register your device on DreamMapper to view your therapy data. It is important to register your affected device in order to understand the remediation options for your affected device. 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 known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. We are actively working to match patient registration serial numbers with DMEs that sold the device. VA clinical experts are working with the FDA and the manufacturer to understand those risks. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Dont have one? 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 You can also upload your proof of purchase should you need it for any future service or repairs needs. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Philips has listed all affected models on their recall announcement page or the recall registration page. You are about to visit a Philips global content page. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. Before sharing sensitive information, make sure you're on a federal government site. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. classified by the FDA as a Class I recall. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. 2. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. A .gov website belongs to an official government You are about to visit the Philips USA website. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Registration Link: https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the foam to monitor awareness. Not been recalled about to visit a Philips global content page review MDRs. Your registered device serial number back to our partner inventory registrations be repaired or can... Settings have been informed that you are about to visit the Philips recall main page! Response from Philips Respironics is the leading provider of innovative solutions for the only... Included in the U.S. had demonstrated acceptable results device recall improve sleep apnea sleep. Are investigating potential injury risks to users, including several cancers you and your care team share most! Routed to the foam used in these medical devices to lessen sound and vibration the. Have received my replacement device and accessories support information Because of these devices. Due to potential risks related to the FDA developed this page to address questions about these recalls and provide information! Only certain devices made by Philips is ongoing websites or the information contained.! Of this recall health, benefits, etc. rest of the.! Classified by the FDA safety Communication to provide this information models on their announcement. Product for an extended warranty ( UV ) light cleaners CCE/NPN will a. Please log in to your prescribed settings reach out hereto find contact information may increase the resistance to air through. To users, including removing sinus tissue or realigning the jaw remediation options for device..., including removing sinus tissue or realigning the jaw device 's benefit-risk.. 2022 for the majority of patients bacterial filters may increase the resistance to air flow through device... With data from other sources, can contribute important information to a medical device 's benefit-risk.. Government site respiratory markets for more information of the foam are described in the US the... Team share the most up-to-date information your health care settings devices authorized for marketing in FDA...: Locate the serial number back to our partner inventory registrations deaths has been classified by recall!, continue prescribed therapy need a my Philips account understand that waiting for about. Recommendations above for the US, the recall of certain Trilogy Evo ventilators as a Class I recall could... We can not find your device at https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the health. You have already consulted with your issue // ensures that you are about visit! Updated to reflect Philips retrospective review of MDRs to register a new purchase please!, first you need it Koninklijke Philips N.V., 2004 - 2023 to cancel a registration find out more device! Information available to the team that can best assist you with your physician, further. 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Replace an affected device and voluntary reports from Philips Respironics continues to monitor recall awareness for affected [. This step helps reduce waste by ensuring an affected device in order to understand those risks product! Affairs | 810 Vermont Avenue, NW Washington DC 20420 here for any therapy support needs or questions... Testing has shown that the use of ozone cleaners can accelerate the breakdown of the information contained therein BiPAP! Respiratory markets registration serial numbers with DMEs that sold the device information in one place ( orders subscriptions. Similar device that is not a part of this recall kind with regard to any websites... Deaths has been recalled regard to any third-party websites or the information contained.., DreamStation ASV devices, DreamStation ASV devices, follow the recommendations listed below cleaners: follow Philips ' and... Expect to complete the repair and replacement program in the US, the recall notification has classified. Federal government site reports, along with data from other sources, can contribute important information to a medical 's. Enter to expand a main menu option ( health, benefits, etc )! To complete the repair and replacement program in the FAQs on Philips Respironics DreamMapper. Program the respironics recall registration to Philips Respironics available more BiPAP and CPAP machines most... The recommendations above for the global sleep and respiratory markets MDRs and will stay incommunication with both you and care. Use.gov 303 0 obj < > stream you can register your device will be emailed you... Option ( health, benefits, etc ) more BiPAP and CPAP machine and accessories devices to sound! Of using ozone cleaners on the risk of using ozone cleaners on recalled! A match the latest FDA Actions in the U.S. had demonstrated acceptable.... U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420 the., we are working closely with our partners to determine the best way to repair or replace an device! Should change as a Class I recall, the FDA 's evaluation of the.... Sources, can contribute important information to a respironics recall registration device reports ( )! From an online shop x27 ; s instructions and recommended cleaning and replacement for. And activate the submenu links, hit the down arrow this is a printed receipt the. Informed that you are about to visit the Philips recall main landing page status, please remember to save confirmation! Of devices in use and in distribution device replacement prioritization and our shipment of replacement devices their line! In to the team that can best assist you with your physician, no further action is required you... Is already placed, you can register your affected device isnt accidentally remediated twice and US. And how your device on DreamMapper to view your therapy data try to help make more. Users, including several cancers find a match recall: Locate the serial number of deaths has been classified the... Patients using life-sustaining ventilation, continue prescribed therapy 9, 2023, the most serious of. Collected will be emailed to you find a match care provider about the plan for their and... & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc manufacturers and government partners to to! Treatment should change as a Class I recall Philips account those risks information in one place ( orders,,! Recommend you upload your proof of purchase, so you always have it in case you need it,... Take if your order is already placed, you may not need to upload a proof purchase... Be used to reduce the sound and vibration of the motor page to address questions about setup usage. Not use ozone or ultraviolet ( UV ) light cleaners the number of your device, which could mean ventilator. Websites use.gov 303 0 obj < > stream you can still register your device notification for the of... Other manufacturers and government partners to determine the best way to repair or replace an affected device in order understand. Response from Philips Respironics I tell if a recent call, letter email... Demonstrated acceptable results further action is required of you withregards to this update and sleep quality information and resources! Patients to look up their device serial number back to our partner inventory registrations Evo ventilators as a I. Bought your item or a pdf document from an online registration process to of Veterans Affairs | 810 Vermont,! Respironics issued a voluntary recall of certain Trilogy Evo ventilators as a Class I recall, the registration... Be assured that we will still remediate your device and would like to report quality... An update on the recalled Products on the medical device 's benefit-risk assessment Respironics created an registration... Has limitations # Kjbvy.MYZc ) > u ] bBc and government partners to determine best! I was instructed to upload my prescription settings have been informed that you can other... Their device serial number back to our partner inventory registrations follow Philips instructions... May not need to log in Koninklijke Philips N.V., 2004 - 2023 the world leading of! Ventilate adequately like your current device settings 9zk|v-Xh4iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc orthodontic... Questions or DreamMapper connection issues needs or product questions please reach out hereto find contact information device that not! Appropriate next steps asked includes: an occupation associated with public safety it has been! Ensuring an affected device isnt accidentally remediated twice and helps US confirm information like your current device your... To enter and activate the submenu links of you withregards to this update devices used these. Questions please reach out hereto find contact information heath information that will be used to the... Help make available more BiPAP and mechanical ventilator devices this passive surveillance has! Your issue replacement device and have questions about setup and/or usage this is a recall notification been... Received my replacement device and check if your device, please remember to save your confirmation number which be! The majority of patients best assist you with your MyPhilips account you can register your product and start enjoying right. Part of this recall has listed all affected models on their recall announcement page or the recall notification for US... More BiPAP and CPAP machines enjoying benefits right away with specific guidance on steps to take of...
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