respironics recall registration

By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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. We are actively working to match patient registration serial numbers with DMEs that sold the device. Only clean your device according to the manufacturers recommendations. Please note: only certain devices made by Philips are subject to this recall. 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 would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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 . The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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 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. . All rights reserved. Do not use ozone or ultraviolet (UV) light cleaners. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. You can log in or create one here. Philips Respironics Sleep and Respiratory Care devices, 2. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. This will come with a box to return your current device to Philips Respironics. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. Apologize for any inconvenience. You can still register your device on DreamMapper to view your therapy data. If youre interested in providing additional information for the patient prioritization, check your order status. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. You can also upload your proof of purchase should you need it for any future service or repairs needs. Philips Sleep and respiratory care. You are about to visit the Philips USA website. . Call us at +1-877-907-7508 to add your email. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. The 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Repairing and replacing the recalled devices. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Cleaning, setup and return instructions can be found here. 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. 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. Didn't include your email during registration? 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. What information do I need to provide to register a product? Please check the Patient Portal for updates. The relevant heath information that will be asked includes: An occupation associated with public safety. Very small particles from the foam could break lose and come through the air hose. There are no updates to this guidance. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. For further information about your current status, please log into the portal or call 877-907-7508. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Philips has listed all affected models on their recall announcement page or the recall registration page. 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. 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. I have received my replacement device and have questions about setup and/or usage. We will automatically match your registered device serial number back to our partner inventory registrations. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. If it has all the elements needed, we will enter an order for your replacement. 2. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. The FDA's evaluation of the information provided by Philips is ongoing. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. VA clinical experts are working with the FDA and the manufacturer to understand those risks. 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. CHEST MEMBERSHIP About Membership . *. Philips has listed all affected models on their recall announcement page or the recall registration page . 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. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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