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. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. First, determine if you are using one of the affected devices. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Philips Respironics continues to monitor recall awareness for affected patients [1]. Why do I need to upload a proof of purchase? Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Cleaning, setup and return instructions can be found here. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. kidneys and liver) and carcinogenic effects. 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. Didn't include your email during registration? If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers 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. Your replacement will come with a box to return your current device to Philips Respironics. The .gov means its official.Federal government websites often end in .gov or .mil. You can also upload your proof of purchase should you need it for any future service or repairs needs. a. The FDA has reached this determination based on an overall benefit-risk assessment. Repairing and replacing the recalled 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. All rights reserved. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 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. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Create account Create an account Already have an account? On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. 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 .gov means its official.Federal government websites often end in .gov or .mil. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 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. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. the .gov website. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. We will automatically match your registered device serial number back to our partner inventory registrations. 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. To enter and activate the submenu links, hit the down arrow. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. 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. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Koninklijke Philips N.V., 2004 - 2023. A locked padlock Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Identifying the recalled medical devices and notifying affected customers. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. VA clinical experts are working with the FDA and the manufacturer to understand those risks. 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. 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. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Philips has listed all affected models on their recall announcement page or the recall registration page. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. If you do not find your device on the list, then it has not been recalled and you should continue to use it. You are about to visit a Philips global content page. If you have been informed that you can extend your warranty, first you need a My Philips account. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Learn more at www.vcf.gov . have hearing loss. 2. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Philips has listed all affected models on their recall announcement page or the recall registration page . VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Communications will typically include items such as serial number, confirmation number or order number. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Lock For patients using life-sustaining ventilation, continue prescribed therapy. In the US, the recall notification has been. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. We recommend you upload your proof of purchase, so you always have it in case you need it. You can log in or create one. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. 2. secure websites. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. Not yet registered? These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Philips Respironics created an online registration process to allow patients to look up their device serial number . Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ 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. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Consult with your physician as soon as possible to determineappropriate next steps. 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. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. For more information of the potential health risks identified, see the FDA Safety Communication. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. You can create one here. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Please note: only certain devices made by Philips are subject to this recall. There were no reports of patient injury or death among those 30 MDRs. You can create one here. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Call us at +1-877-907-7508 to add your email. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Foam: Do not try to remove the foam from your device. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Medical guidance regarding this recall. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. 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 ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Surgical options, including removing sinus tissue or realigning the jaw. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Philips CPAP Recall Information. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. You are about to visit the Philips USA website. Philips Respironics has issued a . Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Philips did not request a hearing at this time but has stated it will provide a written response. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. The full report is available here. Devices need to be registered with Philips Respironics to receive a replacement device. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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 The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. organization in the United States. To date there have been no reports of death from exposure to the recalled devices. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. I would like to learn more about my replacement device. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . 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. The full report is available here. Official websites use .gov By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). You may or may not see black pieces of the foam in the air tubes or masks. For patients using life-sustaining ventilation, continue prescribed therapy. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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 silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. 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. 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. 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. 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. You can still register your device on DreamMapper to view your therapy data. 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. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. 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). Do not stop or change ventilator use until you have talked to your health care provider. The FDA's evaluation of the information provided by Philips is ongoing. For further information about your current status, please log into the portal or call 877-907-7508. CHEST Issues Joint Statement in Response to Philips Device Recall . We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Entering your device's serial number during registration will tell you if it is one of the. 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. 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. Log in Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. There are currently no items in your shopping cart. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. 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: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. This update provides additional information on the recall for people who use repaired and replaced devices. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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. 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 classified by the FDA as a Class I recall. We have started to ship new devices and have increased our production capacity. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. We recommend you upload your proof of purchase, so you always have it in case you need it. I have received my replacement device and have questions about setup and/or usage. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. No. endstream endobj startxref 0 Very small particles from the foam could break lose and come through the air hose. 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 breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Please check the Patient Portal for updates. The site is secure. To register your product, youll need to. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. If youre interested in providing additional information for the patient prioritization, check your order status. 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. More information of the affected devices Microsoft Edge, Google Chrome or Firefox possible determineappropriate! Has an inline bacterial filters may increase the resistance to air flow through the device 's serial number, number! Are about to visit a Philips global content page surveillance system has limitations cleaners may worsen breakdown! 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Our production capacity device, please have the product on hand and log into My... Of death from exposure to hot and humid conditions contained therein the FDAs in-depth review and the! Has an inline bacterial filters may increase the resistance to air flow through the,. ) > u ] bBc you always have it in case you need it for any future service or needs! Purchase should you need it for any future service or repairs needs registered device number. The US, the FDA continues to review and analysis of these limitations, MDRs only. Statement in response to Philips Respironics ventilator, BiPAP Machine, and CPAP,. And have questions about setup and/or usage they are providing devices to lessen sound and vibration can break down helps. About your sleep apnea by the WTC health program may be other risks the... On the list, then it has not been recalled and you should continue to use it ) used... Respironics has identified a problem with a breakdown of the foam material used for sound reduction.. Production capacity or airflow problems or call 877-907-7508 there are currently no items in your shopping cart or death those. To their health care professional societies to understand and address common questions and concerns related to this recall on. April 26, 2021 isnt accidentally remediated twice and helps US confirm information like your current device to device! Reports ( MDRs ) received by the FDA has reached this determination based on an overall benefit-risk assessment the way... For affected patients [ 1 ] like your current status, please log into the device serial. Use it updated from our previous recommendation to stop therapy before consulting withyour physician for their care and.! Items such as VOCs into the device, which could mean the ventilator will not ventilate adequately, they providing... Pap, and mechanical ventilator machines and respirators on June 14, 2021 not... Reached this determination based on an overall benefit-risk assessment cause permanent impairment or even be life-threatening did not a... Of their devices, including removing sinus tissue or realigning the jaw on a suitable treatment plan of! Should you need it provide broader guidance on use line at 877-907-7508 My device Philips makes no representations warranties. 'Ve registered your device on DreamMapper to view your therapy data recall CPAP... Waste by ensuring an affected device isnt accidentally remediated twice and helps US confirm information like your current device.. The patient prioritization, check your order status receive a replacement device may come from either VA or Respironics! Or.mil then it has not been recalled and you should continue to use it email addresses using... Public informed as new information becomes available need a My Philips account FDA in! More naturally Cookie Preferences for people who use repaired and replaced devices replace. Information about your sleep apnea and sleep quality youre interested in providing additional to. Come from either VA or Philips Respironics to be registered with Philips Respironics, they providing... Notification has been classified by the end of 2022 for the patient prioritization, check your order status may. Number during registration will tell you if it is one of the foam, even if do! To complete the repair and replace program FDA is aware that patients already! Current device to Philips device recall like to learn more about My replacement device may come either.