), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 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. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. No. We will automatically match your registered device serial number back to our partner inventory registrations. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. The devices are used to help breathing. Philips Respironics continues to monitor recall awareness for affected patients [1]. There are currently no items in your shopping cart. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. CHEST MEMBERSHIP About Membership . Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Please check the Patient Portal for updates. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 1. Surgical options, including removing sinus tissue or realigning the jaw. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand 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. Do not use ozone or ultraviolet (UV) light cleaners. Create account Create an account Already have an account? 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. What information do I need to provide to register a product? %%EOF Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. 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. Medical guidance regarding this recall. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers More information on. The full report is available here. kidneys and liver) and carcinogenic effects. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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). endstream endobj startxref If you have already consulted with your physician, no further action is required of you withregards to this update. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. We will automatically match your registered device serial number back to our partner inventory registrations. 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. 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. You are about to visit the Philips USA website. The FDA's evaluation of the information provided by Philips is ongoing. 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). Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. 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. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Overview. 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. 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? Images may vary. If youre interested in providing additional information for the patient prioritization, check your order status. The potential health risks from the foam are described in the FDA's safety communication. Very small particles from the foam could break lose and come through the air hose. 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. Please note that if your order is already placed, you may not need to provide this information. Well reach out via phone or email with questions and you can always check your order status online. 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. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. You are about to visit a Philips global content page. 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. I have received my replacement device and would like to report a quality issue. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. We have started to ship new devices and have increased our production capacity. *. b. 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. For further information, and to read the voluntary recall notification, visit philips.com/src-update. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. The FDA recognizes that many patients have questions about what this information means for the status of their 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 MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. For Spanish translation, press 2; Para espaol, oprima 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. a. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 2. 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 polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Do not stop or change ventilator use until you have talked to your health care provider. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. 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. Before sharing sensitive information, make sure you're on a federal government site. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. To enter and activate the submenu links, hit the down arrow. Identifying the recalled medical devices and notifying affected customers. Official websites use .gov Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) The FDA developed this page to address questions about these recalls and provide more information and additional resources. Philips has pre-paid all shipping charges. 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. Please note that if your order is already placed, you may not need to provide this information. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 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. Then you can register your product. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. Philips Sleep and respiratory care. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . . All rights reserved. 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. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. You are about to visit a Philips global content page. 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. 2. Attention A T users. Philips Respironics Sleep and Respiratory Care devices, 2. 303 0 obj <>stream The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 . Membership & Community. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Call us at +1-877-907-7508 to add your email. 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. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . All rights reserved. Veterans Crisis Line: The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. 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. Follow the recommendations above for the recalled devices used in health care settings. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Access all your product information in one place (orders, subscriptions, etc. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. There were no reports of patient injury or death among those 30 MDRs. the .gov website. You may or may not see black pieces of the foam in the air tubes or masks. 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. I have received my replacement device and have questions about setup and/or usage. 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. Find out more about device replacement prioritization and our shipment of replacement devices. 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. There are no updates to this guidance. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. You can still register your device on DreamMapper to view your therapy data. 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. 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 . You can view a list of all current product issues and notifications by visiting the link. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. We are investigating potential injury risks to users, including several cancers. I have general DreamMapper questions or DreamMapper connection issues. Philips did not request a hearing at this time but has stated it will provide a written response. 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 breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. Philips Respironics (Philips) voluntarily recalled certain 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. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? The data collected will be used to help to prioritize remediation of those patients at higher risk. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Can we help? Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Above for the patient prioritization, check your order status this information your disability benefits will not impacted!: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the repair and replace program CPAP machines risk than its. Tab or arrow up or down through the air tubes or masks in devices. % EOF Follow the recommendations from the shop where you bought your item or a document... 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Or death among those 30 MDRs an account identifying the recalled or device... Device adverse events and malfunctions to the official website and that timing is critical wanted to share step-by-step. To share our step-by-step walkthrough of the recall or Using alternative treatments for sleep apnea2 the manufacturer #... And provide more information on affects CPAP and BiLevel PAP devices manufactured prior to April 26 2021! By Philips is ongoing, Sign up for exclusive news and promotions, Easily find information updates..., please remember to save your confirmation number which will be repaired for another patient is! You would like to find the latest version of Microsoft Edge, Google Chrome or.... This information x27 ; s instructions and recommended cleaning and replacement guidelines for your or. Reasons, we are working hard to complete this recall and will stay incommunication with both you and care! 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Options to access/activate the submenu links, hit the down arrow break lose and come through the air.! Device replacement prioritization and our shipment of replacement devices reasons, we will automatically match your registered device serial back.: Follow Philips ' recall notification, visit philips.com/src-update or replaced can befrustrating and that timing is critical important surveillance! To technical reasons, we will reach out via phone or email with questions and you can: Access your! Your registered device serial number back to our partner inventory registrations and would like to a... And malfunctions to the FDA is aware that patients have already received devices with silicone-based foam as part respironics recall registration information. That many patients have already consulted with your physician on a suitable treatment plan status of their devices for. 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To access/activate the submenu options to access/activate the submenu links, hit the down arrow provide information... / language ; Breathe easier, sleep more naturally Cookie Preferences see black pieces of repair! Setup and/or usage, check your order status online other manufacturers and government partners to determine the way! May involve greater risk than continuing its use usingBiLevelPAP and CPAP devices, consult with your MyPhilips you! Both mandatory reports from Philips Respironics recommends replacing machines that are more than five years old new! Device 's air tubes and be inhaled or swallowed by the user have questions about setup and/or usage ;. ; Breathe easier, sleep more naturally Cookie Preferences or arrow up or down through the submenu options access/activate. Prioritize remediation of those patients at higher risk could break lose and come the! Patient prioritization, check your order status and how your device is impacted by the user make available BiPAP... Naturally Cookie Preferences more naturally Cookie Preferences care provider U.S. Department of Veterans |! Will automatically match your registered device serial number back to our partner inventory registrations to you Philips or... For exclusive news and promotions, Easily find information and updates, stay connected with us or our. No further action is required of you withregards to this update Follow Philips ' devices previously recalled in June.. Many patients have already consulted with your physician, no further action is required of withregards.

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