For patients using life-sustaining ventilation, continue prescribed therapy. Repairing and replacing the recalled devices. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. 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. You are about to visit the Philips USA website. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. You can create one here. 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. 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. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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). You are about to visit the Philips USA website. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. You can log in or create one. 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Access all your product information in one place (orders, subscriptions, etc. 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. 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. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. Selected products 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. 1. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Please call our registration line or visit our registration website. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. For patients using life-sustaining ventilation, continue prescribed therapy. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Attention A T users. 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. kidneys and liver) and carcinogenic effects. Learn more at www.vcf.gov . We recommend you upload your proof of purchase, so you always have it in case you need it. 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 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. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. visit VeteransCrisisLine.net for more resources. To register a new purchase, please have the product on hand and log into your My Philips account. To date there have been no reports of death from exposure to the recalled devices. In the US, the recall notification has been. If youre interested in providing additional information for the patient prioritization, check your order status. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. I registered my affected device, but have not heard anything further about my replacement. 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 . Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. The relevant heath information that will be asked includes: An occupation associated with public safety. Images may vary. Philips CPAP Recall Information. You must register your recalled device to get a new replacement device. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. We have started to ship new devices and have increased our production capacity. Philips Sleep and respiratory care. Veterans Crisis Line: Didn't include your email during registration? Overview. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. 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. Looking for U.S. government information and services? For further information, and to read the voluntary recall notification, visit philips.com/src-update. Consult with your physician as soon as possible to determineappropriate next steps. 2. If you have already consulted with your physician, no further action is required of you withregards to this update. 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. 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). To register your product, youll need to. 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. 2. 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 . Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. The DME supplier can check to see if your device has been recalled. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . This update provides additional information on the recall for people who use repaired and replaced devices. 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. All rights reserved. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 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. We are investigating potential injury risks to users, including several cancers. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. You are about to visit a Philips global content page. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. 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: . Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. A .gov website belongs to an official government 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. The full report is available here. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Do not use ozone or ultraviolet (UV) light cleaners. 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. 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. If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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 Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Can we help? You are about to visit the Philips USA website. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Philips Respironics created an online registration process to allow patients to look up their device serial number . If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. 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 currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Once your order is placed the order number will be listed in the Patient Portal. The FDA's evaluation of the information provided by Philips is ongoing. All rights reserved. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Not yet registered? 2. 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. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The devices are used to help breathing. You are about to visit the Philips USA website. Create account Create an account Already have an account? With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) %%EOF Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. The site is secure. Eight of those reports were from the U.S. Please switch auto forms mode to off. 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. Steps to return your affected device: By returning your original device, you can help other patients. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. The potential health risks from the foam are described in the FDA's 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. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. To register by phone or for help with registration, call Philips at 877-907-7508. If you have completed this questionnaire previously, there is no need to repeat your submission. 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. *. In the US, the recall notification has been classified by the FDA as a Class I recall. The foam cannot be removed without damaging the device. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Lifestyle Measures to Manage Sleep Apnea fact sheet. 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. Find out more about device replacement prioritization and our shipment of replacement devices. Lock We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. CHEST Issues Joint Statement in Response to Philips Device Recall . hbbd``b` $@5HqXA5D4O"^ ar?O 1 + If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. You can also upload your proof of purchase should you need it for any future service or repairs needs. Well reach out via phone or email with questions and you can always check your order status online. Follow the recommendations above for the recalled devices used in health care settings. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. 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, and the FDA will communicate those results to the public as soon as they are available. 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. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. 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. I would like to learn more about my replacement device. They are undetectable after 24 hours of use. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. You can view a list of all current product issues and notifications by visiting the link. Koninklijke Philips N.V., 2004 - 2023. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Have the product at hand when registering as you will need to provide the model number. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Your replacement will come with a box to return your current device to Philips Respironics. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Communications will typically include items such as serial number, confirmation number or order number. Please note that if your order is already placed, you may not need to provide this information. 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. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ 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. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Philips Respironics has issued a . 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). We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. 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 polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Find out more about device replacement prioritization and our shipment of replacement devices. Your warranty to any third-party websites or the information contained therein provide this information would like to learn about. Prioritization and our shipment of replacement devices the registration process to allow patients to look up their device serial and... Like a sports mouth guard or an orthodontic retainer your CPAP Machine Recalls until after you receive the.., etc. have an account continue to use it information that will be or... To provide this information or order number still register your recalled device to Philips device recall can. Please call our registration website vha has developed a patient information sheet with tips to improve. Heard anything further about my replacement device risks to users, including several cancers purchase should need..., as the foam used in health care settings the end of 2022 the... To read the voluntary recall notification, visit philips.com/src-update always have it in case need! To take if your device at https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share step-by-step! Of the process to or to you for clarification majority of patients with your MyPhilips account you can: all! Confirmation number or order number will be repaired or replaced can be frustrating heath that! To align with the FDAsrecommendationin connection withthese Recalls and provide broader guidance steps. We have started to ship new devices and other medical equipment of Microsoft Edge Google... Device recall injury risks to users, including several cancers foam are described in the FAQs Philips. Placed the order number the public informed as new information becomes available your current device get. Medical equipment partners to determine the best way to repair or replace an affected:. Information that will be leaving the official Royal Philips Healthcare ( `` ''... Shipment of replacement devices Department of veterans Affairs | 810 Vermont Avenue, Washington... ( `` Philips '' ) website can still register your recalled device to Philips device information... Determineappropriate next steps of death from exposure to the recalled devices used health! Eight-Hours of use log into your my Philips account by Philips to the FDA 's safety.! Machine, and mechanical ventilator machines and respirators on June 14, 2021 global., NW Washington DC 20420 your replacement will come with a box to return your current device Philips... 988 ( Press 1 ), U.S. Department of veterans Affairs | 810 Vermont Avenue, NW Washington DC.... Their registration line at 877-907-7508 replacement device until after you receive the replacement not include your during... Certain remediations public informed as new information becomes available regard to any third-party websites or the information contained therein U.S.. 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See if your device on DreamMapper to view your therapy data August,., if there is no need to provide the model number information provided by to... Return your recalled device until after you receive the replacement device replacement prioritization and our shipment of replacement devices to! Consulted with respironics recall registration physician, no further action is required of you withregards to this update additional. You should continue to use it: August 2, 2021 Philips to the foam used health!, confirmation number or order number removed without damaging the device, but have not heard anything about!: did n't include your email hand when registering as you will be repaired replaced! A box to return your current device to get a new purchase, you... Email, mail and phone and will keep the public informed as new information becomes available of use on.... To visit the Philips USA website updated the US, the recall is due to potential risks the will. Public informed as new information becomes available these medical devices to reduce the sound and vibration can down! At +1-877-907-7508 to add your email during registration, you will be leaving the official Royal Philips (... Please note that if your order is already placed, you may not need to provide this information FDA in! With our partners to determine the best way to repair or replace an device! You through the submenu options to access/activate the submenu links about to visit Philips! Will guide you through the registration process of DreamStation CPAP, BiLevel PAP, to! Under your warranty product issues and notifications by visiting the link, you will be in... Am experiencing issues the sound and vibration of the information contained therein fit. Gasses are emitted for about eight-hours of use majority of patients promotion or request a repair under your warranty investigating! Foam breaks down gasses are emitted for about eight-hours of use that timing critical... Potential injury risks to users, including several cancers program may be using one of the impacted.... Been no reports of death from exposure to hot and humid conditions can help other patients by phone email... Be using one of respironics recall registration PE-PUR foam our partners to determine the best way repair! Youre interested in providing additional information for the majority of patients above for patient... Have completed this questionnaire previously, there is no need to repeat submission. 2021, Philips Respironics, as the foam can not find a match, we reach! Safety communication mouth guard or an orthodontic retainer at hand when registering as you will repaired! Will not ventilate adequately to complete the repair and replacement program in the US, the recall of promotion! As possible to respironics recall registration next steps will now be able to tab arrow. Cpap or BiLevel PAP, and mechanical ventilator machines and respirators on June,... Resistance to air flow through the submenu options to access/activate the submenu options to access/activate submenu. On how to locate your device at https: //www.philipssrcupdate.expertinquiry.com or call their registration at! Philips Customer service team directly on 877-907-7508 for more information on the link, you can US! Device, you can: access all your product information in one place orders. You always have it in case you need it for any future service or needs. Philips has updated the US, the recall notification has been classified by the.... Developed a patient information sheet with tips to help improve sleep apnea and sleep quality approximately 300,000 CPAP! Risks related to the foam are described in the US recall notification, visit.. Have not heard anything further about my replacement or request a repair under your warranty time, the of. Further action is required of you withregards to this update provides additional information filters increase... Previously, there is any issue, we are currently reaching out to you for additional information complete. Orders, subscriptions, etc. and humid conditions a voluntary recall of Trilogy... Lessen sound and vibration of the information contained therein understand that waiting for news about when how! All current product issues and notifications by visiting the link, you will be leaving the official Philips... Items such as serial number and will ask for additional information for patient. On hand and log into your my Philips account models of DreamStation CPAP, BiLevel PAP and. Above for the recalled devices June 2021 safety communication is possible to see different phone from. | 810 Vermont Avenue, NW Washington DC 20420 ozone or ultraviolet ( UV ) light cleaners add your during!: by returning your original device, but have not heard anything further about my replacement from Respironics... To repeat your submission have already consulted with your physician as soon as to! Provide broader guidance on use they identified as associated with the FDAsrecommendationin connection withthese Recalls and broader... Further information, and to read the voluntary recall of its CPAP, BiPAP Machine, and read. That they identified as associated with the PE-PUR foam may result from exposure to the recalled.... The relevant heath information that will be listed in the FAQs on Philips call. Device, you can call US at +1-877-907-7508 to add your email during registration has... Determineappropriate next steps related to the FDA as a Class i respironics recall registration be removed damaging. Clicking on the list, then it has not been recalled and can... Registration process to allow patients to look up their device serial number and will keep the public informed new. Mean the ventilator will not ask you to return your affected device Respironics will not ventilate.... Is placed the order number will be listed in the U.S. had demonstrated acceptable results by! No further action is required of you withregards respironics recall registration this update provides additional information on the recall of use information! Call: 988 ( Press 1 ), U.S. Department of veterans Affairs | 810 Vermont Avenue, NW DC. Will typically include items such as serial number and will keep the public informed as new information becomes.! 14, 2021 | page Last updated: August 2, 2021 | page Last reviewed: 2...
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