My issue is not addressed here. 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. Keep your registration confirmation number. All rights reserved. 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. A locked padlock Follow the recommendations above for the recalled devices used in health care settings. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. There are no updates to this guidance. 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. Medical guidance regarding this recall. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? For any therapy support needs or product questions please reach out hereto find contact information. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Use another similar device that is not a part of this recall. You must register your recalled device to get a new replacement device. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . . On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. 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. By returning your original device, you can help other patients. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The data collected will be used to help to prioritize remediation of those patients at higher risk. For Spanish translation, press 2; Para espaol, oprima 2. If we cannot find a match, we may reach out to you for additional information. You can still register your device on DreamMapper to view your therapy data. If you are in crisis or having thoughts of suicide, If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. If you use one of these recalled devices, follow the recommendations listed below. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. We are actively working to match patient registration serial numbers with DMEs that sold the device. 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. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. You can log in or create one. What information do I need to provide to register a product? First, determine if you are using one of the affected devices. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. No. Are there any other active field service notifcations or recalls of Philips Respironcs products? Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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 . 2. If you have already consulted with your physician, no further action is required of you withregards to this update. 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. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. a. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Please check the Patient Portal for updates. Koninklijke Philips N.V., 2004 - 2023. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. 1. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. benefits outweigh the risks identified in the recall notification. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). You are about to visit a Philips global content page. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Images may vary. CDRH will consider the response when it is received. 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. 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. All rights reserved. kidneys and liver) and carcinogenic effects. Didn't include your email during registration? 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. The .gov means its official.Federal government websites often end in .gov or .mil. 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. We are investigating potential injury risks to users, including several cancers. 1. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. The data collected will be used to help to prioritize remediation of those patients at higher risk. We have started to ship new devices and have increased our production capacity. 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. 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. There are no updates to this guidance. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. If you have been informed that you can extend your warranty, first you need a My Philips account. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. You are about to visit the Philips USA website. 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 created an online registration process to allow patients to look up their device serial number . Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. If you do not find your device on the list, then it has not been recalled and you should continue to use it. endstream endobj startxref In the US, the recall notification has been classified by the FDA as a Class I recall. For patients using life-sustaining ventilation, continue prescribed therapy. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. I would like to learn more about my replacement device. 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. 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. Selected products The more we know about these devices the more research we can do.". 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 . Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Official websites use .gov These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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