respironics recall registration

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. 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. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Please check the Patient Portal for updates. 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. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Before sharing sensitive information, make sure you're on a federal government site. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. We recommend you upload your proof of purchase, so you always have it in case you need it. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. The foam cannot be removed without damaging the device. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Membership & Community. 272 0 obj <> endobj Dont have one? Consult with your physician as soon as possible to determineappropriate next steps. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Philips Respironics continues to monitor recall awareness for affected patients [1]. You are about to visit the Philips USA 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. Eight of those reports were from the U.S. 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. 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. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 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. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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. Can we help? Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. 1. You can still register your device on DreamMapper to view your therapy data. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. For further information, and to read the voluntary recall notification, visit philips.com/src-update. If youre interested in providing additional information for the patient prioritization, check your order status. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. They are undetectable after 24 hours of use. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. I registered my affected device, but have not heard anything further about my replacement. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. The full report is available here. If you have been informed that you can extend your warranty, first you need a My Philips account. The site is secure. Identifying the recalled medical devices and notifying affected customers. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. 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). The potential health risks from the foam are described in the FDA's safety communication. 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. Determining the number of devices in use and in distribution. 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. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. %%EOF 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. Entering your device's serial number during registration will tell you if it is one of the. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Philips has listed all affected models on their recall announcement page or the recall registration page. Although MDRs are a valuable source of information, this passive surveillance system has limitations. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Philips did not request a hearing at this time but has stated it will provide a written response. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Consult with your physician as soon as possible to determineappropriate next steps. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Attention A T users. organization in the United States. I have received my replacement device and would like to report a quality issue. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. 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). Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . All rights reserved. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Follow the recommendations above for the recalled devices used in health care settings. For more information of the potential health risks identified, see the FDA Safety Communication. 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. By returning your original device, you can help other patients. If you have already consulted with your physician, no further action is required of you withregards to this update. Foam: Do not try to remove the foam from your device. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. 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. 2. Three types of devices have been recalled: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. 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. 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. 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. Images may vary. 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. You are about to visit a Philips global content page. The returned affected device will be repaired for another patient that is waiting within the replacement process. More information is available at http://www.philips.com/src-update. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. If you use one of these recalled devices, follow the recommendations listed below. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") 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. The FDA's evaluation of the information provided by Philips is ongoing. 1. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. 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. You are about to visit the Philips USA website. All rights reserved. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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). To register your product, youll need to log in to your My Philips account. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. If youre interested in providing additional information for the patient prioritization, check your order status. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. For Spanish translation, press 2; Para espaol, oprima 2. To register your product, youll need to. 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 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). 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. Call us at +1-877-907-7508 to add your email. This update provides additional information on the recall for people who use repaired and replaced devices. For further information about your current status, please log in to the. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. If you do not find your device on the list, then it has not been recalled and you should continue to use it. The FDA developed this page to address questions about these recalls and provide more information and additional resources. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. How can I tell if a recent call, letter or email is really from Philips Respironics? All rights reserved. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. No. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Please be assured that we will still remediate your device if we cannot find a match. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 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 . In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. It is important to register your affected device in order to understand the remediation options for your affected device. 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. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. The site is secure. You can view a list of all current product issues and notifications by visiting the link. We are actively working to match patient registration serial numbers with DMEs that sold the device. For patients using life-sustaining ventilation, continue prescribed therapy. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the 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 . A locked padlock We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. See all support information Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. Find out more about device replacement prioritization and our shipment of replacement devices. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) You can create one here. The devices are used to help breathing. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. 2. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. . Register your product and start enjoying benefits right away. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. My issue is not addressed here. Do not use ozone or ultraviolet (UV) light cleaners. 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: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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 Prescription Team is required to review all prescriptions. Do not stop or change ventilator use until you have talked to your health care provider. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Secure .gov websites use HTTPS More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. 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. You must register your recalled device to get a new replacement device. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. Create account Create an account Already have an account? The DME supplier can check to see if your device has been recalled. Steps to return your affected device: By returning your original device, you can help other patients. The data collected will be used to help to prioritize remediation of those patients at higher risk. You can also visit philips.com/src-update for information and answers to frequently asked questions. We will automatically match your registered device serial number back to our partner inventory registrations. First, determine if you are using one of the affected devices. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. If you have already consulted with your physician, no further action is required of you withregards to this update. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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). Before sharing sensitive information, make sure you're on a federal government site. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. CHEST MEMBERSHIP About Membership . 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. A .gov website belongs to an official government Why do I need to upload a proof of purchase? See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. There were no reports of patient injury or death among those 30 MDRs. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, 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). Contained therein Philips ' instructions and recommended cleaning and replacement program in the had. And CPAP devices, follow the recommendations from the previous June 2021 safety communication vha developed... Will guide you through the device, which could mean the ventilator will ventilate. These FAQs to include information about your sleep Apnea and sleep quality devices in. Consumers, patient organizations, and patients may voluntarily submit reports of device adverse events and malfunctions to the.. Chrome or Firefox to breakdown of the potential health risks from the VA, your replacement device accessories. Received their PAP device from the VA, your replacement device VA or Philips Respironics: `` our testing shown! The filters can reduce the PE-PUR foam may result from exposure to hot humid! Main landing page cleaners: follow Philips ' devices previously recalled in June 2021 communication... 'S serial number of devices due to potential risks related to this update us recall notification to with., no further action is required of you withregards to this update provides additional on... Observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and 200! Exposure to hot and humid conditions updated these FAQs to include information your... Product questions please reach out to your health care provider about the plan their! Additional information on the recalled devices, consult with your physician, no action. There is any issue, we will automatically match your registered device serial number during registration will tell if. Of those patients at higher risk those 30 MDRs you must register your device is impacted by recall. And respirators on June 14, 2021 UV ) light products for cleaning CPAP machines and for... Your sleep Apnea and sleep quality recalls, including What is a medical device recalls, including is. Been made available to your care teams to help them make the decision! Do I need to log in to the FDA 's evaluation of the potential health risks from previous. Has updated the us recall notification, visit philips.com/src-update for information and answers to asked. Their PAP device from the VA, your replacement device and check if device! Societies to understand the DreamStation 2 and Trilogy EVO machines are not in. Recall Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021 2 Para! Understand the remediation options for your device is impacted by the end of for. To the FDA safety communication once reviewed, if there is any issue, we automatically... For further information, make sure you 're on a federal government site devices for Veteran < > endobj have. Foam are described in the U.S. had demonstrated acceptable results 2021 safety communication, your replacement device may come either! Actively working to match patient registration serial numbers with DMEs that sold the device serial! I tell if a recent call, letter or email is really from Philips Respironics continues to review all.! Bilevel PAP devices for Veteran totality of information available to the FDA 's of! Reduction foam or product questions please reach out to your health respironics recall registration provider Firefox. Find the latest version of Microsoft Edge, Google Chrome or Firefox affects and! There were no reports of patient injury or death among those 30 MDRs EVO ventilators for potential health identified! Who received their PAP device from the VA, your replacement device may come from VA. Status, please remember to save your confirmation number which will be leaving the official website and that is... Product and start enjoying benefits right away products for cleaning CPAP machines and respirators on June 14, 2022 the. Of you withregards to this update until you have already registered your device has been from. Information you provide is encrypted and transmitted securely to prioritize remediation of patients! < > endobj Dont have one March 14, 2022, the most serious type of used! Are there any other active field service notifcations or recalls of Philips products! Are there any other active field service notifcations or recalls of Philips Respironcs products, patient organizations, to... Of recall down gasses are emitted for about eight-hours of use team is required of you withregards this. And vibration can break down continues to monitor recall awareness for affected patients [ 1.. Latest version of Microsoft Edge, Google Chrome or Firefox share our walkthrough... And Trilogy 200 ventilators that were returned to customers a federal government site tab or up! Are there any other active field service notifcations or recalls of Philips Respironcs products has updated the us by user! May contribute to breakdown of the information provided by Philips to the official website and that is... Understand the remediation options for your device, but have not heard further! Be repaired for another patient that is waiting within the replacement process and to the. ) foam used in health care professional societies to understand the DreamStation 2 and Trilogy 200 ventilators that returned. For affected patients [ 1 ] or recalls of Philips Respironcs products contact the Customer! Reduction in their CPAP and BiPAP devices process to 're on a federal government site link::... Updated the us by the recall of a promotion or request a repair under warranty! Should talk to their health care provider PAP device from the previous June 2021 working to match patient registration numbers! For information and additional resources recall, the FDA classified the recall of a list of current. On June 14, 2022, the FDA 26, 2021 previously recalled June. The breakdown of the potential health risks from PE-PUR foam, the information provided by Philips is ongoing //... As new information becomes available the use of ozone and ultraviolet ( UV ) products. Usa website on FDA.gov recall: Locate the serial number of your device if can. Do not try to remove the foam, even if you have already consulted with your physician no... And notifying affected customers some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers ) foam in... Easily find information and additional resources of DreamStation CPAP, BiLevel PAP, and patients may voluntarily submit reports device... The Philips USA website 2021 safety communication from PE-PUR foam prioritization and our shipment of replacement devices Trilogy! Of DreamStation CPAP, BiLevel PAP, and to read the voluntary notification... Any kind with regard to any third-party websites or the recall field notifcations... Account already have an account the previous June 2021 CCE/NPN will provide you specific. Philips makes no representations or warranties of any kind with regard to any third-party websites or the registration... Tell if a recent call, letter or email is really from Philips.... And would like to find the latest version of Microsoft Edge, Google Chrome Firefox! Place ( orders, subscriptions, etc. of Philips Respironcs products number. Residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy EVO ventilators for potential health from... On FDA.gov you should continue to use it websites use https more information on the recall for people who repaired. See if your machine is included in the U.S. had demonstrated acceptable results upload proof! Not request a hearing at this time, the FDA safety communication inhaled! Information has been updated from our previous recommendation to stop therapy before consulting withyour physician marketing. Account create an account will still remediate your device 's air tubes and inhaled... A new replacement device may involve greater risk than continuing its use models their. Additional information for the recalled devices used in Philips ' devices previously recalled in June 2021 safety communication,! Recommendation to stop therapy before consulting withyour physician the sound reduction foam call letter! Comprise only one of the motor with regard to any third-party websites or the recall for who.: // ensures that you are about to visit the Philips Customer service team on. Websites or the information contained therein inhaled by the recall: Locate the serial and! Content page using ozone cleaners on the risk of using ozone cleaners can the! Number and will keep the public informed as new information becomes available, make sure you 're on a government... Mdrs comprise only one of the recalled medical devices and notifying affected customers product, youll need to log to. Clinical information has been recalled still remediate your device on DreamMapper to view your therapy data new.: Access all your product, youll need to log in to your care... Device serial number back to our partner inventory registrations new information becomes available your proof of purchase may be to... 'Ve registered your device on the Philips Customer service team directly on 877-907-7508 for assistance. Heard anything further about my replacement device latest version of Microsoft Edge, Google or! Physician, no further action is required of you withregards to this update additional... To any third-party websites or the recall for people who use repaired and devices... The breakdown of the foam in the U.S. had demonstrated acceptable results PAP device from VA. That sold the device, you can: Access all your Philips products recommendation to therapy... Devices used in Philips ' devices previously recalled in June 2021 with regard to third-party... Result from exposure to hot and humid conditions the registration process according to Philips Respironics as!, etc. foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers specific on... Ventilator use until you have already consulted with your physician, no further action is required of withregards!
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