We may request contact information, date of birth, device prescription or physician information. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. 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. A .gov website belongs to an official government 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. organization in the United States. Register your product and start enjoying benefits right away. 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. In the US, the recall notification has been. The devices are used to help breathing. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. secure websites. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. 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. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. I have received my replacement device and have questions about setup and/or usage. Call us at +1-877-907-7508 to add your email. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers 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. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. For further information about your current status, please log in to the. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Consult with your physician as soon as possible to determineappropriate next steps. 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. 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. Secure .gov websites use HTTPS Koninklijke Philips N.V., 2004 - 2023. 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 Be cautious as they may be scams! 0 Do not use ozone or ultraviolet (UV) light cleaners. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 1. To access the menus on this page please perform the following steps. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Is there a question we can answer for you? Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. By returning your original device, you can help other patients. If you are in crisis or having thoughts of suicide, 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. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. a. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. The full report is available here. You can also visit philips.com/src-update for information and answers to frequently asked questions. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For patients using life-sustaining ventilation, continue prescribed therapy. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 2. 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. Lifestyle Measures to Manage Sleep Apnea fact sheet. The more we know about these devices the more research we can do.". 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. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. More information is available at http://www.philips.com/src-update. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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. Devices need to be registered with Philips Respironics to receive a replacement device. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. There are no updates to this guidance. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Please switch auto forms mode to off. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. 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. CHEST MEMBERSHIP About Membership . Didn't include your email during registration? Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. 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. Your replacement will come with a box to return your current device to Philips Respironics. 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. If you have completed this questionnaire previously, there is no need to repeat your submission. Register your product and start enjoying benefits right away. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. 2. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. 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. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. I registered my affected device, but have not heard anything further about my replacement. We may request contact information, date of birth, device prescription or physician information. kidneys and liver) and carcinogenic effects. If we cannot find a match, we may reach out to you for additional information. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Please call us so we can get your question routed to the team that can best assist you with your issue. We recommend you upload your proof of purchase, so you always have it in case you need it. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. 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. Please note: only certain devices made by Philips are subject to this recall. 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). Dont have one? You can create one here. 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 continues to monitor recall awareness for affected patients [1]. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 272 0 obj <> endobj 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. 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. You are about to visit a Philips global content page. 1. 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. Cleaning, setup and return instructions can be found here. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. The foam cannot be removed without damaging the device. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. See the FDA Safety Communication for more information. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Select country / language; Breathe easier, sleep more naturally Cookie Preferences . You can log in or create one. 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 . Find out more about device replacement prioritization and our shipment of replacement devices. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. To monitor recall awareness for affected patients [ 1 ] and Respiratory care devices please log in to FDA. For all CPAP and BiPAP and start enjoying benefits right away, if there any... Breakdown ) we will reach out to your doctor or to you for additional information right.. 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