Be cautious as they may be scams! 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. Koninklijke Philips N.V., 2004 - 2023. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. I registered my affected device, but have not heard anything further about my replacement. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. . *The number of deaths has been updated to reflect Philips retrospective review of MDRs. More information on. We have started to ship new devices and have increased our production capacity. 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. 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. 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. %%EOF These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Apologize for any inconvenience. Do not stop or change ventilator use until you have talked to your health care provider. Identifying the recalled medical devices and notifying affected customers. Selected products For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . I have received my replacement device and have questions about setup and/or usage. See the FDA Safety Communication for more information. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. 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. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. I would like to learn more about my replacement device. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. To register a new purchase, please have the product on hand and log into your My Philips account. No. Repairing and replacing the recalled devices. 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. To register your product, youll need to log in to your My Philips account. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. You are about to visit the Philips USA website. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. More information is available at http://www.philips.com/src-update. Please note that if your order is already placed, you may not need to provide this information. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. Register your product and start enjoying benefits right away. Register your product and start enjoying benefits right away. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. The devices are used to help breathing. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers The FDA's evaluation of the information provided by Philips is ongoing. 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. How can I register my product for an extended warranty? The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. The returned affected device will be repaired for another patient that is waiting within the replacement process. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Consult with your physician as soon as possible to determineappropriate next steps. Be aware that during the 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 certain chemicals of concern, called volatile organic compounds (VOCs). Medical guidance regarding this recall. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. There were no reports of patient injury or death among those 30 MDRs. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Veterans Crisis Line: Please note: only certain devices made by Philips are subject to this recall. Philips Respironics Sleep and Respiratory Care devices, 2. 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. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. All rights reserved. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. 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. If you have already consulted with your physician, no further action is required of you withregards to this update. Call us at +1-877-907-7508 to add your email. For patients using life-sustaining ventilation, continue prescribed therapy. 2. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Very small particles from the foam could break lose and come through the air hose. 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. To date there have been no reports of death from exposure to the recalled devices. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Please check the Patient Portal for updates. Entering your device's serial number during registration will tell you if it is one of the. The potential health risks from the foam are described in the FDA's safety communication. 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. Eight of those reports were from the U.S. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. the .gov website. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. 0 To register your product, youll need to log in to your My Philips account. 1. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. Foam: Do not try to remove the foam from your device. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. It may also lead to more foam or chemicals entering the air tubing of the device. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. For further information about your current status, please log into the portal or call 877-907-7508. Membership & Community. The FDA recognizes that many patients have questions about what this information means for the status of their devices. Steps to return your affected device: By returning your original device, you can help other patients. There are no updates to this guidance. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. You must register your recalled device to get a new replacement device. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . The full report is available here. The data collected will be used to help to prioritize remediation of those patients at higher risk. Well reach out via phone or email with questions and you can always check your order status online. Please switch auto forms mode to off. The more we know about these devices the more research we can do.". A lock ( Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. Dont have one? Lock 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. First, determine if you are using one of the affected devices. Communications will typically include items such as serial number, confirmation number or order number. 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. 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. You are about to visit the Philips USA website. See all support information 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). If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. 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. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. Please visit the Patient Portalfor additional information on your status. We will automatically match your registered device serial number back to our partner inventory registrations. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. Philips Respironics created an online registration process to allow patients to look up their device serial number . This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. We recommend you upload your proof of purchase, so you always have it in case you need it. CHEST Issues Joint Statement in Response to Philips Device Recall . These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The full report is available here. It is important to register your affected device in order to understand the remediation options for your affected device. Koninklijke Philips N.V., 2004 - 2023. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. Before sharing sensitive information, make sure you're on a federal government site. You are about to visit a Philips global content page. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance 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. Can we help? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 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. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. 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. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics continues to monitor recall awareness for affected patients [1]. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. 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. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. 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. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. Consult with your physician as soon as possible to determineappropriate next steps. The data collected will be used to help to prioritize remediation of those patients at higher risk. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. If you have been informed that you can extend your warranty, first you need a My Philips account. 2. 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. Cleaning and replacement guidelines for your affected device, but have not anything! Entering your device 's serial number back to our partner inventory registrations: do see... To reflect Philips retrospective review of MDRs an online registration process to allow patients to look up device! As soon as possible to determineappropriate next steps EOF these issues may result in serious that. 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