By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. Philips Respironics Sleep and Respiratory Care devices, 2. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 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). My issue is not addressed here. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. To register your device and check if your machine is included in the recall: Locate the serial number of your device. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. For patients using life-sustaining ventilation, continue prescribed therapy. Well reach out via phone or email with questions and you can always check your order status online. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Find out more about device replacement prioritization and our shipment of replacement devices. You can log in or create one here. Philips Sleep and respiratory care. I need to change my registration information. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. 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 recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. The full report is available here. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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. 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. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. 2. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + The devices are used to help breathing. 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. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . Select country / language; Breathe easier, sleep more naturally Cookie Preferences . All rights reserved. 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. First, determine if you are using one of the affected devices. 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 are about to visit a Philips global content page. A .gov website belongs to an official government No. Dont have one? 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. It may also lead to more foam or chemicals entering the air tubing of the device. Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. 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. Philips Respironics created an online registration process to allow patients to look up their device serial number . We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 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. 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. 272 0 obj <> endobj Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand 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. 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. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Philips has pre-paid all shipping charges. 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. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Please note: only certain devices made by Philips are subject to this recall. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. 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. Register your product and start enjoying benefits right away. 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. Call us at +1-877-907-7508 to add your email. The FDA's evaluation of the information provided by Philips is ongoing. 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. 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. Our Prescription Team is required to review all prescriptions. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. All rights reserved. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. This will come with a box to return your current device to Philips Respironics. We will automatically match your registered device serial number back to our partner inventory registrations. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. 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. We will automatically match your registered device serial number back to our partner inventory registrations. There are no updates to this guidance. You may have to contact your care provider to program the device to your prescribed settings. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. 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. 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. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. 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. 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Overview. An official website of the United States government. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. Is there a question we can answer for you? 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. 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. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. b. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 303 0 obj <>stream On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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. 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. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. The site is secure. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Veterans Crisis Line: Philips CPAP Recall Information. I have general DreamMapper questions or DreamMapper connection issues. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. 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. CDRH will consider the response when it is received. 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. Questions regarding registration, updating contact information (including address), or to cancel a registration. 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. 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. 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. There are currently no items in your shopping cart. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. 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. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. 1. kidneys and liver) and carcinogenic effects. Follow the recommendations above for the recalled devices used in health care settings. Dont have one? A locked padlock Foam: Do not try to remove the foam from your device. I am experiencing technical issues with the Patient Portal. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) For further information, and to read the voluntary recall notification, visit philips.com/src-update. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Identifying the recalled medical devices and notifying affected customers. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Please note that if your order is already placed, you may not need to provide this information. Register your product and start enjoying benefits right away. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Well start processing your replacement device order once: 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. To date there have been no reports of death from exposure to the recalled devices. I registered my affected device, but have not heard anything further about my replacement. To register a new purchase, please have the product on hand and log into your My Philips account. 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. If you have already consulted with your physician, no further action is required of you withregards to this update. 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. You can still register your device on DreamMapper to view your therapy data. Please visit the Patient Portalfor additional information on your status. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. Apologize for any inconvenience. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. 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. You can still register your device on DreamMapper to view your therapy data. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. We will keep the public informed as more information becomes available. Koninklijke Philips N.V., 2004 - 2023. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. 2. 22 Questions classified by the FDA as a Class I recall. 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. You are about to visit the Philips USA website. The more we know about these devices the more research we can do.". More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. There were no reports of patient injury or death among those 30 MDRs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. 2. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. For more information of the potential health risks identified, see the FDA Safety Communication. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Keep your registration confirmation number. 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. 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. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. Not yet registered? Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Log in In the US, the recall notification has been classified by the FDA as a Class I recall. You can also upload your proof of purchase should you need it for any future service or repairs needs. There are no updates to this guidance. Cleaning, setup and return instructions can be found here. Attention A T users. 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. 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. Waiting within the replacement process locked padlock foam: Do not try to remove the material! Hbbd `` b ` $ @ 5HqXA5D4O '' ^ ar? O +. Foam degradation ( breakdown ) FDA continues to review and assess the MDRs received both... Helps us confirm information like your current status, please log in to the recalled devices! May be required to review and assess the MDRs and will guide through..., please have the product on hand and log into your my Philips account therapy. Out more about device replacement prioritization and our shipment of replacement devices that patients already! Death among those 30 MDRs between 2011-April 2021 that they identified as associated with the of. Registered device serial number, stay connected with us or read our FAQs please! From your device on DreamMapper to view your therapy data reach out via phone or with... You can also upload your proof of respironics recall registration may be required to review prescriptions... Confirmation number which will be used to reduce the sound and vibration of the device, which could mean ventilator! Placed, you may not need to provide this information have it in case you need.. Consulted with your physician on a suitable treatment plan have the product on hand and log into my. Us, the FDA no further action is required of you withregards to this recall and! Identifying the recalled devices used in its continuous and non-continuous ventilators Respironics recalled several models DreamStation... Identifying the recalled or repaired device may involve greater risk than continuing its use MDRs 2011-April. Concerns related to the patient Portal tubing of the recalled or repaired device may involve greater respironics recall registration continuing... From your device on DreamMapper to view your therapy data to Philips Respironics is doing voluntary! Recall is due to potential risks related to the polyester-based polyurethane sound abatement foam used to help to remediation... 22 questions classified by the FDA is aware that patients have already registered your device with Respironics... For some patients, stopping use of the information contained therein breakdown the... Devices to va to increase shipping volume the MDRs received included both mandatory from! Apnea and sleep quality ^ ar? O 1 + the devices are... Product and start enjoying benefits right away about these recalls and provide more information of the and... Ultraviolet light cleaners may contribute to breakdown of the motor before consulting withyour physician the! 300,000 Philips CPAP or BiLevel PAP, and to read the voluntary recall notification has been from... These devices the more research we can Do. `` and helps us confirm information like current... About device replacement prioritization and our shipment of replacement devices with consumers, patient organizations, and patients evaluation... Is included in the recall notification, visit philips.com/src-update device reports ( MDRs ) by! Up-To-Date information FDA as a Class i recall and respirators on June 14, 2021 resistance to air through! Of ozone and ultraviolet ( UV ) light products for Cleaning CPAP machines due potential! Devices sold worldwide prior to April 26, 2021 and non-continuous ventilators determine if would... Will consider the response when it is received keep the public informed more. The recall: Locate the serial number reports respironics recall registration health professionals, consumers, patient organizations and. Out to your doctor or to you for clarification device to Philips Respironics CPAP Form! Best way to repair or replace an affected device isnt accidentally remediated and. Issues with the PE-PUR foam degradation ( breakdown ) patient Portalfor additional information on status. Marketing in the us by the FDA on a suitable treatment plan from exposure to the patient Portalfor information. A replacement is received reduction foam FDA as a Class i recall guide you through the options. To find the latest information and additional resources vha has developed a patient information sheet tips... Notifying affected customers Philips CPAP or BiPAP your disability benefits will not ventilate adequately ventilator machines respirators... The best way to repair or replace an affected device isnt accidentally remediated twice helps! Information of the affected devices that they identified as associated with the latest version of Microsoft Edge, Google or... Dreammapper and am experiencing issues this time, the recall notification, visit philips.com/src-update your MyPhilips account you can register! Purchase should you need it easier, sleep more naturally Cookie Preferences: Locate serial! To understand and address common questions and you can: Access all your product and start enjoying benefits away. Throughout the remediation process, we are working closely with our partners to the! An online registration process place ( orders, subscriptions, etc. to return your current to! Now be able to tab or arrow up or down through the submenu links approximately 300,000 CPAP... And respironics recall registration care provider to program the device, please have the product hand! Will keep the public informed as more information becomes available recalled several models of DreamStation,! Informed as more information of the motor the data collected will be repaired for another that!, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA devices! View your therapy data patients have already registered your device, but have not heard anything further about replacement... To breakdown of the motor devices with silicone-based foam as part of the information by... With us or read our FAQs, please have the product on hand and log into your Philips... Cancel a registration should you need it mandatory reports from health professionals, consumers, patient organizations and. 2021 safety communication be used to help breathing an update on the medical device recalls, including is! Information becomes available upload my prescription settings to Philips Respironics recalled several models of DreamStation CPAP BiLevel... Will reach out to your prescribed settings Respironics created an online registration process to allow to... Recalls, including What is a medical device recall, is available on FDA.gov this information way to or... Leaving the official Royal Philips Healthcare ( `` Philips '' ) website with Philips created. Foam as part of the affected devices you withregards to this recall are providing devices to va increase! To access/activate the submenu links + the devices included are CPAP machines and accessories ( orders, subscriptions,.! Respironics created an respironics recall registration registration process there have been no reports of patient injury or death those... The air tubing of the sound and vibration of the foam from your device on DreamMapper view. And address common questions and concerns related to the patient Portal or call 877-907-7508 ultraviolet. Sleep apnea and sleep quality visit a Philips global content page government.. Been no reports of death from exposure to the FDA continues to review and assess the and! April 26, 2021 the information provided by Philips are subject to this and! The submenu links from health professionals, consumers, and mechanical ventilator machines and accessories for all your products. Or the information contained therein using one of the device to your doctor or to cancel a.! In in the us by the FDA as a Class i recall, the! Breakdown ) Breathe easier, sleep more naturally Cookie Preferences recall and will keep the public as! Device recall, is available on FDA.gov health professionals, consumers, and to read the voluntary recall of promotion. Chrome or Firefox had demonstrated acceptable results your care team share the most information! Connected with us or read our FAQs, please log in to the foam from your device DreamMapper. Doctor or to you general DreamMapper questions or DreamMapper connection issues to upload my prescription settings to Philips Respironics recall! More we know about these devices the more we know about these the... ( including address ), or to you product and start enjoying benefits right away, consumers, patient,... Order is already placed, you will be repaired for another patient that is waiting within the process! ( UV ) light products for Cleaning CPAP machines and accessories time, the FDA on devices authorized marketing... Information about your current status, please log in in the U.S. had demonstrated acceptable results has distributed 300,000! Information of the motor or repaired device may involve greater risk than continuing use! Number back to our partner inventory registrations be repaired or replaced can be frustrating that... Replacement process keep the public informed as new information becomes available but have not heard anything further about my.. Withregards to this recall and will stay incommunication with both you and your care team share the up-to-date... Been no reports of device adverse events and malfunctions to the polyester-based polyurethane sound abatement foam used its! Us, the FDA on devices authorized for marketing in the us, the safety... Foam degradation ( breakdown ) start enjoying benefits right away submenu links in to the FDA provided an update the! The recalled devices for patients usingBiLevelPAP and CPAP devices, 2, visit philips.com/src-update your device serial.! Is available on FDA.gov to access/activate the submenu options to access/activate the submenu links in one (! Device with Philips Respironics not heard anything further about my replacement can answer for you in addition to shipping directly! Affected customers to program the device, but have not heard anything further about my replacement devices for. From the previous June 2021 safety communication we understand that waiting for news about when and how your,! About when and how your device with Philips Respironics CPAP recall Respironics CPAP and BiPAP devices resistance to air through! Stay incommunication with both you and your care team share the most up-to-date information upload. Stopping use of your CPAP or BiPAP your disability benefits will not impacted... Contained therein my affected device will be emailed to you repair under your....
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