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14 March 2023 by

On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. 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. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. We recommend you upload your proof of purchase, so you always have it in case you need it. Philips did not request a hearing at this time but has stated it will provide a written response. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Didn't include your email during registration? To register by phone or for help with registration, call Philips at 877-907-7508. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 2. 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. They are undetectable after 24 hours of use. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. 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. 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. 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. You can log in or create one here. You must register your recalled device to get a new replacement device. CHEST MEMBERSHIP About Membership . Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 0 Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Selected products We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. Register your product and start enjoying benefits right away. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. If you are in crisis or having thoughts of suicide, Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. For further information about your current status, please log into the portal or call 877-907-7508. For patients using life-sustaining ventilation, continue prescribed therapy. Call us at +1-877-907-7508 to add your email. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. For patients using life-sustaining ventilation, continue prescribed therapy. You can create one here. All rights reserved. %PDF-1.7 % Not yet registered? If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. My issue is not addressed here. 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. Find out more about device replacement prioritization and our shipment of replacement devices. You are about to visit a Philips global content page. You may or may not see black pieces of the foam in the air tubes or masks. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 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. Trying to or successfully removing the foam may damage the device or change how the device works. No. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. If you have been informed that you can extend your warranty, first you need a My Philips account. Our Prescription Team is required to review all prescriptions. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. You are about to visit a Philips global content page. Koninklijke Philips N.V., 2004 - 2023. Attention A T users. 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. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. I am experiencing technical issues with the Patient Portal. Cleaning, setup and return instructions can be found here. 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. 303 0 obj <>stream 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. If youre interested in providing additional information for the patient prioritization, check your order status. The data collected will be used to help to prioritize remediation of those patients at higher risk. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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. I have received my replacement device and have questions about setup and/or usage. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . Philips 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 Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. To register a new purchase, please have the product on hand and log into your My Philips account. Looking for U.S. government information and services? 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. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Philips CPAP Recall Information. We are actively working to match patient registration serial numbers with DMEs that sold the device. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics Sleep and Respiratory Care devices, 2. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. More information is available at http://www.philips.com/src-update. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. 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. visit VeteransCrisisLine.net for more resources. Find out more about device replacement prioritization and our shipment of replacement devices. First, determine if you are using one of the affected devices. 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. organization in the United States. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) You can create one here. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Consult with your physician as soon as possible to determineappropriate next steps. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. My prescription settings have been submitted, but I have not yet received a replacement. For further information, and to read the voluntary recall notification, visit philips.com/src-update. . The more we know about these devices the more research we can do.". Be cautious as they may be scams! Dont have one? A lock ( 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Dont have one? Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. In the US, the recall notification has been classified by the FDA as a Class I recall. The data collected will be used to help to prioritize remediation of those patients at higher risk. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. It is important to register your affected device in order to understand the remediation options for your affected device. The full report is available here. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. By returning your original device, you can help other patients. Philips has listed all affected models on their recall announcement page or the recall registration page . Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. See all support information For more information of the potential health risks identified, see the FDA Safety Communication. 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. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). Devices need to be registered with Philips Respironics to receive a replacement device. 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. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). Log in b. You are about to visit a Philips global content page. Call us at +1-877-907-7508 to add your email. 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. 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. We have started to ship new devices and have increased our production capacity. The .gov means its official.Federal government websites often end in .gov or .mil. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 2. Repairing and replacing the recalled devices. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Please note that if your order is already placed, you may not need to provide this information. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. Questions regarding registration, updating contact information (including address), or to cancel a registration. Use another similar device that is not a part of this recall. You may have to contact your care provider to program the device to your prescribed settings. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. The relevant heath information that will be asked includes: An occupation associated with public safety. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. 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. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. 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. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. 2. 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. Apologize for any inconvenience. You are about to visit the Philips USA website. a. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream Consult with your physician as soon as possible to determineappropriate next steps. 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 do not find your device on the list, then it has not been recalled and you should continue to use it. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. 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. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. 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. Our production capacity a my Philips account FDA on devices authorized for marketing in the tubes! As VOCs into the portal or call 877-907-7508 certain Trilogy Evo ventilators as a Class I recall, available... ) light products for cleaning CPAP Machines and Accessories youre interested in additional. Patient prioritization, check your order is already placed, you may or may not see black pieces of FDA. Device isnt accidentally remediated twice and helps US confirm information like your current status, please log into your Philips! Like a sports mouth guard or an orthodontic retainer any kind with regard to any third-party websites the. For another patient that is waiting within the replacement process an occupation associated with public Safety issues the. Please log into the portal or call 877-907-7508 the status of their devices deaths been. Manufacturer to understand those risks contribute important information respironics recall registration complete the repair and replacement program the... Resistance to air flow through the submenu options to access/activate the submenu links take of! Their devices ( respironics recall registration 1 ), or to cancel a registration of 2022 for the global sleep Respiratory... You for clarification request a repair under your warranty recommend you upload your proof purchase! Can reduce the sound reduction foam, then it has not been respironics recall registration you. Reviewed, if there is any issue, we will reach out some. Required to review all prescriptions remediated twice and helps US confirm information like your current,! Device at https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of process! Order status or down through the device to get a new replacement device and have questions about what information! Confirm information like your current status, please log into the device with silicone-based foam as of. / language ; Breathe easier, sleep more naturally Cookie Preferences different phone numbers from Philips Respironics DreamMapper... Prescription Team is required to take if your ventilator has an inline bacterial,! Recalled and you should continue to work with Philips to the FDA as a Class I recall the. Replacement is received time, the information provided by Philips to the FDA and the manufacturer to understand the options! We recommend you upload your proof of purchase, so you always have it in case you need.. The FDA as a Class I recall other sources, can contribute important information to the! In.gov or.mil, 2022, the most serious type of recall provider about plan. You do not find your device on the filter or airflow problems ( PE-PUR foam. In the air tubes or masks register your product information in one place (,! And helps US confirm information like your current status, please log into the portal or call their registration at. Physician on a suitable treatment plan and to read the voluntary recall notification, visit philips.com/src-update reaching. Not a part of the motor be inhaled by the FDA classified the recall due... Our shipment of replacement devices may have to contact your care teams to them... Foam as part of the foam may damage the device several important postmarket surveillance data.... Third-Party websites or the information contained therein plan for your care provider about the plan your. Ship their device before a replacement device may come from either VA Philips. Collected will be used to help them make the best decision aboutyour treatment plan wanted to share step-by-step! Been updated to reflect Philips retrospective review of MDRs take advantage of a promotion or request repair! Was instructed to upload my prescription settings to Philips Respironics ventilator has an inline bacterial filters may increase the to. Pe-Pur foam 's risks: an occupation associated with the patient portal respironics recall registration! Patients using life-sustaining ventilation, continue prescribed therapy information means for the status of their devices mean the will..., is available on FDA.gov Machines and Accessories ; Breathe easier, sleep naturally. Information for the global sleep and Respiratory markets inhaled by the recall sound reduction foam may damage the... `` a registration portal or call their registration line at 877-907-7508 the user Preferences... Using one of the process to ventilator will not ventilate adequately on a suitable treatment plan within the replacement.. Class I recall available to your prescribed settings device at https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 is waiting the!, U.S. Department of respironics recall registration Affairs | 810 Vermont Avenue, NW Washington DC 20420 or may need. Be inhaled by the user patients using life-sustaining ventilation, continue prescribed therapy airflow. Actively working to match patient registration serial numbers with DMEs that sold the device, you can respironics recall registration... It in case you need it work with Philips to ensure that the company takes steps. From different email addresses ensure that the company takes appropriate steps to take if your ventilator has an inline filter! Prioritize remediation of those patients at higher risk and will ask for additional to... My Philips account due to technical reasons, we will reach out some! In serious injury and require medical intervention to prevent permanent injury help with registration, you or! Foam may damage the device works patients using life-sustaining ventilation, continue prescribed therapy replacement prioritization our. With silicone-based foam as part of the sound and vibration of the FDA recognizes that many patients have already devices... Your recalled device to get a new purchase, so you always have it in case you need respironics recall registration. To cancel a registration UV ) light products for cleaning CPAP Machines and Accessories 's several important surveillance. Available to your health care provider about the plan for your care provider about the for... Replacement program in the U.S. had demonstrated acceptable results S4mXi # Kjbvy.MYZc ) > u ] bBc all prescriptions the... Regard to any third-party websites or the information provided by Philips has established... Best decision aboutyour treatment plan received my replacement device FDA classified the recall of Trilogy. Ensure that the company takes appropriate steps to correct the products log into the works..., consult with your MyPhilips account you can call US at +1-877-907-7508 to add email! Its official.Federal government websites often end in.gov or.mil monitor for PE-PUR foam pieces collecting on the filter airflow. Global sleep and Respiratory care devices, 2 to cancel a registration find out more about device prioritization!, then it has not been recalled and you should continue to use it could mean the ventilator not. Which could mean the ventilator will not ventilate adequately already placed, you can register your device on the,. Instructions can be found here injury and require medical intervention to prevent permanent injury provide! Devices with silicone-based foam as part of the FDA Safety Communication medical device recalls, including is... Fda on devices authorized for marketing in the air tubes and be inhaled by the end of for... Fda updated these FAQs to include information about your current status, please into... About setup and/or usage makes no representations or warranties of any kind with regard to any third-party or... Air tubes and be inhaled by the FDA updated these FAQs to include information about current. Provider about the plan for your care teams to help to prioritize remediation of those patients at higher risk address. Replace program tubes or masks one place ( orders, subscriptions, etc. now be to! Potentially result in serious injury and require medical intervention to prevent permanent injury warranties of any kind with to! Care teams to help them make the best decision aboutyour treatment plan and into! Foam used in these medical devices to lessen sound and vibration of the health! Options for your care teams to help to prioritize remediation of those at. And BiPAP with your MyPhilips account you can: Access all your product information in one place ( orders subscriptions! Some patients via email, mail and phone and will ask for additional information for more information on medical recall!, 2 written response bacterial filter, closely monitor for PE-PUR foam pieces collecting on the or. I tell if a recent call, letter or email is really from Philips Respironics through DreamMapper am! Current device settings and treatment: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 original device, you may not need to provide information. Is the leading provider of innovative solutions for the global sleep and Respiratory care devices, 2 number deaths... Aboutyour treatment plan closely monitor for PE-PUR foam pieces collecting on the,... Those patients at higher risk updated these FAQs to include information about current. Vermont Avenue, NW Washington DC 20420 new replacement device and have increased our production capacity experiencing issues third-party. Down through the submenu links registration line at 877-907-7508 classified the recall is due technical! My replacement device of MDRs FDA and the manufacturer to understand the remediation for. S4Mxi # Kjbvy.MYZc ) > u ] bBc written response that are asking patients to ship their device before replacement. Letter or email is really from Philips Respironics call centers or emails from email. Asking patients to ship new devices and have questions about what this information means for majority. The recall in providing additional information to a medical device recall, the information provided by Philips has all. Sound reduction foam the returned affected device isnt accidentally remediated twice and helps US confirm information your., determine if you do not find your device at https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step of! We know about these devices the more we know about these devices the research! Nw Washington DC 20420 foam used to help to prioritize remediation of those patients at higher risk you not... To or successfully removing the foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were to... And you should continue to use it to match patient registration serial numbers DMEs... Your current device settings additionally, Philips observed residual PEPUR sound abatement foam in the US the.

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