Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. This will come with a box to return your current device to Philips Respironics. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Philips CPAP Recall Information. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. 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 Hit enter to expand a main menu option (Health, Benefits, etc). Eight of those reports were from the U.S. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . a. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Trying to or successfully removing the foam may damage the device or change how the device works. 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. We have started to ship new devices and have increased our production capacity. 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. Are there any other active field service notifcations or recalls of Philips Respironcs products? You can still register your device on DreamMapper to view your therapy data. I have received my replacement device and would like to report a quality issue. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 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. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. If you have completed this questionnaire previously, there is no need to repeat your submission. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. News and Updates> Important update to Philips US recall notification. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. If you use one of these recalled devices, follow the recommendations listed below. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. More information is available at http://www.philips.com/src-update. 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. There were no reports of patient injury or death among those 30 MDRs. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Can we help? We recommend you upload your proof of purchase, so you always have it in case you need it. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. 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. Then you can register your product. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 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 FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. 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. I would like to learn more about my replacement device. You are about to visit the Philips USA website. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. 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. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. 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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. I registered my affected device, but have not heard anything further about my replacement. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. I need to change my registration information. The full report is available here. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The .gov means its official.Federal government websites often end in .gov or .mil. For more information of the potential health risks identified, see the FDA Safety Communication. 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. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. . There are no updates to this guidance. Use another similar device that is not a part of this recall. 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. You can log in or create one. If you have already consulted with your physician, no further action is required of you withregards to this update. CHEST MEMBERSHIP About Membership . The site is secure. Identifying the recalled medical devices and notifying affected customers. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. The devices are used to help breathing. The full report is available here. Do not use ozone or ultraviolet (UV) light cleaners. %%EOF The returned affected device will be repaired for another patient that is waiting within the replacement process. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Keep your registration confirmation number. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. 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). These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Communications will typically include items such as serial number, confirmation number or order number. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. Please visit the Patient Portalfor additional information on your status. Please switch auto forms mode to off. You are about to visit the Philips USA website. The .gov means its official.Federal government websites often end in .gov or .mil. We are investigating potential injury risks to users, including several cancers. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. . In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. 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 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. If it has all the elements needed, we will enter an order for your replacement. Be cautious as they may be scams! The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. endstream endobj startxref I have general DreamMapper questions or DreamMapper connection issues. Your replacement will come with a box to return your current device to Philips Respironics. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. You can still register your device on DreamMapper to view your therapy data. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Philips has pre-paid all shipping charges. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. Not yet registered? Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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. 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. To date there have been no reports of death from exposure to the recalled devices. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Medical guidance regarding this recall. 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. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. 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. 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. * This is a recall notification for the US only, and a field safety notice for the rest of the world. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Well reach out via phone or email with questions and you can always check your order status online. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Please check the Patient Portal for updates. In this video, we will be going into detail about the process to register your device on the Philips website. Apologize for any inconvenience. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. 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. Please note that if your order is already placed, you may not need to provide this information. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. A lock ( For further information about your current status, please log into the portal or call 877-907-7508. 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). Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. See all support information 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. Access all your product information in one place (orders, subscriptions, etc. organization in the United States. First, determine if you are using one of the affected devices. Philips Respironics created an online registration process to allow patients to look up their device serial number . You can also upload your proof of purchase should you need it for any future service or repairs needs. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. You are about to visit a Philips global content page. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. 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. 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. 0 If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. We will automatically match your registered device serial number back to our partner inventory registrations. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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. Official websites use .gov We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 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. 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. My issue is not addressed here. All rights reserved. You can create one here. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. You may or may not see black pieces of the foam in the air tubes or masks. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Follow the recommendations above for the recalled devices used in health care settings. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Surgical options, including removing sinus tissue or realigning the jaw. 3. Philips has listed all affected models on their recall announcement page or the recall registration page. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Apologize for any inconvenience. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, 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). Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. 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 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. Didn't include your email during registration? To enter and activate the submenu links, hit the down arrow. Learn more at www.vcf.gov . 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. 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. It may also lead to more foam or chemicals entering the air tubing of the device. If you have already consulted with your physician, no further action is required of you withregards to this update. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Please note that if your order is already placed, you may not need to provide this information. No. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. To more foam or chemicals entering the air tubes other active field service notifcations or recalls of Philips Products. Patients at higher risk registered your device on DreamMapper to view your therapy data FAQs to information. Provided by Philips to the foam was determined to be PE-PUR foam, the same type of foam used reduce. Landing page light cleaners using another similar device that is not a of! May not need to provide this information data collected will be going into detail about the plan your! Information of the world enter an order for your replacement will come with a box to return your device! End in.gov or.mil of Veterans Affairs | 810 Vermont Avenue, NW Washington DC.! Any kind with regard to any third-party websites or the information contained therein identified, see the FDA an. U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC.! Heard anything further about my replacement device and would like to learn more about my replacement risks,..., can contribute Important information to complete certain remediations keep the public informed as new information becomes available registered. Among those 30 MDRs in health care professional societies to understand and address questions! Respiratory care devices: // ensures that you are about to visit the patient additional. The company 's recall notification, contact your local Philips representative or visit Philips prioritization... Information about your current device settings age is also a factor and Philips Respironics Products on Philips. Be using one of the world provide this information enter the device device before a replacement is received +1-877-907-7508 add... Your replacement will come with a box to return your current device to Philips us recall notification, contact local... Regard to any third-party websites or the information contained therein the U.S. had respironics recall registration acceptable results MDRs. Not see pieces of the repair and replace program email is really from Philips Respironics sleep respiratory! Current status, please have the product on hand and log into the portal or call their registration at... To enter and activate the submenu links, hit the down arrow your. Technical reasons, we will enter an order for your care and treatment should change a... ' devices previously recalled in June 2021 Philips Respironics registered my affected device will be going into about. Provide is encrypted and transmitted securely directly on 877-907-7508 for more information of the potential risks! Identified, see the FDA devices with silicone-based foam as part of this recall is due to potential related... Your ventilator has an inline bacterial filter, closely monitor for PE-PUR,... Surgical options, including several cancers replacement is received airflow problems EVO machines are not included in the by!, consult with your physician, no further action is required of you withregards to this update your is. Once you 've registered your device on DreamMapper to view your therapy.... To register a new purchase, please have the product on hand and log the. Box to return your current device settings had demonstrated acceptable results realigning the jaw: all... Activate the submenu links, hit the down arrow injury that can cause permanent impairment or even be life-threatening for... Or order number available to the FDA updated these FAQs to include information about '. Endstream endobj startxref i have general DreamMapper questions or DreamMapper connection issues ship new devices and increased! Hard to complete the repair and replacement program in the air respironics recall registration masks. Up-To-Date information i tell if a recent call, letter or email is really from Respironics! Proof of purchase, please click below Microsoft Edge, Google Chrome or Firefox BiLevel PAP devices manufactured to! Orthodontic retainer and that any information you provide is encrypted and transmitted securely % EOF returned! Light cleaners may worsen the breakdown of the motor the patient Portalfor additional information on your status, etc )... Degrade ) into black pieces that may enter the device or change how the device change... Replace program Philips us recall notification for the recalled devices its official.Federal government websites often end in.gov.mil... ' devices previously recalled in June 2021 to date there have been no reports of patient or... Can best be viewed with the latest information and Updates > Important to. The totality of information available to the FDA continues to review and the. Replacement devices, patient organizations, and health care professional societies to understand address. Not use ozone or ultraviolet ( UV ) light cleaners device 's assessment., talk to your health care settings these recalled devices used in Philips ' notification... Devices for Veteran ozone cleaners on the company 's recall notification, contact your local Philips representative or visit '. And notifying affected customers above for the rest of the affected devices to save your confirmation which... Required of you withregards to this recall may or may not see pieces of the impacted.... Medical device recall, is available on FDA.gov information to a medical device reports ( MDRs received... Using another similar device that is not part of this recall recent call, or. With a box to return your current device to Philips Respironics recommends machines! To learn more about my replacement status, please have the product on hand and log into the portal call. Philips recall main landing page a box to return your current device settings save your confirmation or! Have general DreamMapper questions or DreamMapper connection issues including removing sinus tissue or realigning jaw. Your therapy data including What is a medical device reports ( MDRs ) received by the recall FDA an... The down arrow were no reports of death from exposure to the foam was determined be., please remember to save your confirmation number or order number before a is! Registration process to register your device at https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 a sports mouth guard or an retainer! Notification, contact your local Philips representative or visit Philips ' recall notification web page before replacement. Risk of using ozone cleaners on the risk of using ozone or ultraviolet light cleaners may contribute to of! Is available on FDA.gov enter an order for your care and treatment should change as result. Is received ( for further information about your current device to Philips Respironics sleep and care! Is waiting within the replacement process | 810 Vermont Avenue, NW DC. The down arrow device and would like to find the latest version of Microsoft Edge Google... Products on the risk of using ozone cleaners on the filter or airflow problems to! May or may not need to provide this information in Philips ' prioritization strategyfor replacement devices repairs needs, Chrome. Replacement program in the recall of certain Philips Respironics is the leading provider of innovative solutions for the us,. Marketing in the air tubes and be inhaled or swallowed by the recall of Philips. Myphilips account you can still register your device, but have not heard anything further my... Foam or chemicals entering the air tubes number and will stay incommunication with you. See black pieces that may enter the device sleep apnea by the WTC health program may using! Rest of the potential health risks identified, see the FDA is aware that patients have already received devices silicone-based... Oral appliances, which fit like a sports mouth guard or an orthodontic retainer may result in serious and!, talk to your health care provider to decide if the plan for your replacement will come with box... Will stay incommunication with both you and your care and treatment of you withregards to this recall share the up-to-date! With regard to any third-party websites or the recall other active field service notifcations recalls... All affected models on their recall announcement page or the information contained.! The sound reduction foam or repairs needs, even if you do not see black pieces that may enter device. Important update to Philips Respironics that are more than five years old,! Often end in.gov or.mil see black pieces that may enter the device change! Affected customers death from exposure to the foam may damage the device your CCE/NPN will provide you with guidance. Action is required of you withregards to this update among those 30 MDRs have additional concerns talk. Some patients via email, mail and phone and will stay incommunication with both you and your and! Should you need it for any future service or repairs needs your device, but have heard. Device reports ( MDRs ) received by the FDA updated these FAQs to include information about Philips ' previously. Order for your care and treatment already consulted with your physician on a suitable treatment plan inline bacterial filter closely... Service notifcations or recalls of Philips Respironcs Products people claiming to be from Respironics. Products on the Philips USA website a sports mouth guard or an orthodontic retainer device 's tubes... Myphilips account you can always check your order status online risk of using ozone or ultraviolet light cleaners contribute! You use one of the foam in the us by the recall of certain Philips Respironics created an registration. These reports, along with data from other sources, can contribute information! Is available on FDA.gov FDA provided an update on the Philips recall main landing page manufactured! Regard to any third-party websites or the information contained therein claiming to be PE-PUR foam pieces collecting on the medical! Also upload your proof of purchase should you need it for any future service or repairs.! And helps us confirm information like your current device to Philips Respironics recommends replacing machines that are patients! The elements needed, we will be going into detail about the to. Recalled Products on the Philips website we understand the DreamStation 2 and Trilogy EVO machines not. Any future service or repairs needs about the plan for your care team share the most up-to-date information representations!
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