respironics recall registration

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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. You are about to visit a Philips global content page. Please call our registration line or visit our registration website. 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. 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. We have started to ship new devices and have increased our production capacity. 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. 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. Philips has pre-paid all shipping charges. If youre interested in providing additional information for the patient prioritization, check your order status. 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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 general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. 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. Your replacement will come with a box to return your current device to Philips Respironics. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Communications will typically include items such as serial number, confirmation number or order number. What information do I need to provide to register a product? You are about to visit a Philips global content page. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. 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. Find out more about device replacement prioritization and our shipment of replacement devices. Identifying the recalled medical devices and notifying affected customers. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). There are currently no items in your shopping cart. 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. 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. CHEST MEMBERSHIP About Membership . 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. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Why do I need to upload a proof of purchase? You can still register your device on DreamMapper to view your therapy data. The full report is available here. Please call us so we can get your question routed to the team that can best assist you with your issue. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 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 VOCs. 1. Call us at +1-877-907-7508 to add your email. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. The full report is available here. 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 is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Dont have one? The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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 will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. No. 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. Do not stop or change ventilator use until you have talked to your health care provider. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Follow the recommendations above for the recalled devices used in health care settings. Keep your registration confirmation number. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. For any therapy support needs or product questions please reach out hereto find contact information. 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. Have the product at hand when registering as you will need to provide the model number. We will automatically match your registered device serial number back to our partner inventory registrations. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. 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. The FDA has reached this determination based on an overall benefit-risk assessment. Register your product and start enjoying benefits right away. You are about to visit the Philips USA website. classified by the FDA as a Class I recall. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You can also upload your proof of purchase should you need it for any future service or repairs needs. If you are in crisis or having thoughts of suicide, Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. 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. More information on the company 's recall notification, contact your local Philips representative or visit Philips ' device... Items such as serial number back to our partner inventory registrations need to provide the number... 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