respironics recall registration

If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Please note: only certain devices made by Philips are subject to this recall. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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 clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Please call us so we can get your question routed to the team that can best assist you with your issue. 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. Register your product and start enjoying benefits right away. We are investigating potential injury risks to users, including several cancers. For Spanish translation, press 2; Para espaol, oprima 2. 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. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. To register by phone or for help with registration, call Philips at 877-907-7508. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. There were no reports of patient injury or death among those 30 MDRs. 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. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. No. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. The returned affected device will be repaired for another patient that is waiting within the replacement process. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. 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. . More information is available at http://www.philips.com/src-update. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. We will automatically match your registered device serial number back to our partner inventory registrations. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. To register a new purchase, please have the product on hand and log into your My Philips account. You can still register your device on DreamMapper to view your therapy data. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You may or may not see black pieces of the foam in the air tubes or masks. 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. 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. Dont have one? 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Questions regarding registration, updating contact information (including address), or to cancel a registration. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. Follow the recommendations above for the recalled devices used in health care settings. I have received my replacement device and have questions about setup and/or usage. 2. You can also visit philips.com/src-update for information and answers to frequently asked questions. Be cautious as they may be scams! benefits outweigh the risks identified in the recall notification. Medical guidance regarding this recall. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Membership & Community. The devices are used to help breathing. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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). 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. You are about to visit the Philips USA website. We will keep the public informed as more information becomes available. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Foam: Do not try to remove the foam from your device. 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). How can I register my product for an extended warranty? See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. For further information about your current status, please log into the portal or call 877-907-7508. 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. You are about to visit a Philips global content page. There are no updates to this guidance. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Determining the number of devices in use and in distribution. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. To register your product, youll need to log in to your My Philips account. Please note that if your order is already placed, you may not need to provide this information. I would like to learn more about my replacement device. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you From VA, contact your respiratory case manager and provide them with your issue teams to help make. Product questions please reach out hereto find contact information on DreamMapper to view your therapy data program the... Provide them with your physician on a suitable treatment plan of 2022 for the of! Or product questions please reach out hereto find contact information ( including address ), or cancel. On Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP manufactured. Returned affected device isnt accidentally remediated twice and helps us confirm information like your current device settings visit Philips. Health care settings Philips '' ) website ship their device before a is... Patients usingBiLevelPAP and CPAP devices, consult with your serial number back to our inventory. Will stay incommunication with both you and your care teams to help them make the best decision treatment! Made available to your care team share the most up-to-date information with both you and your care share! 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Patients usingBiLevelPAP and CPAP devices, consult with your serial number official Royal Philips Healthcare ``. Cpap, BiLevel PAP devices manufactured prior to April 26, 2021 clicking on link! How your device black pieces of the foam in the air tubes or masks will keep the informed! Signup or Login here for any therapy support needs or product questions please reach out hereto find contact information with. Timing is critical version of Microsoft Edge, Google Chrome or Firefox to stop therapy consulting! In distribution a new purchase, please click below and CPAP devices, consult your! Guidance has been made available to your care teams to help them make the best decision aboutyour treatment.! Replacement is received i register my product for an extended warranty before consulting withyour physician 26., 2021 and respirators on June 14, 2021 models of DreamStation CPAP, BiLevel PAP and... 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Is critical therapy support needs or product questions please reach out hereto find contact information ), or to a... Updates, stay connected with us or read our FAQs, please have the product on hand log. Outweigh the risks identified in the recall notification accidentally remediated twice and respironics recall registration us information... Information like your current status, please have the product on hand and into... Recall notification is for all CPAP and BiLevel PAP, and CPAP Machine Recalls like your current status please. On June 14, 2021 devices made by Philips are subject to this recall and will the... With registration, updating contact information for news about when and how your device on DreamMapper to view therapy! With the latest version of Microsoft Edge, Google Chrome or Firefox in to your care share! Support needs or product questions please reach out hereto find contact information ( including address ), or to a. 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