- 11.04.2023respironics recall registration
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respironics recall registration
This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. The FDA has reached this determination based on an overall benefit-risk assessment. 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. 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. I have general DreamMapper questions or DreamMapper connection issues. We may request contact information, date of birth, device prescription or physician information. 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 FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. 0 Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 1. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Entering your device's serial number during registration will tell you if it is one of the. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. You are about to visit the Philips USA website. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. Register your product and start enjoying benefits right away. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Call us at +1-877-907-7508 to add your email. 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. For patients using life-sustaining ventilation, continue prescribed therapy. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. This update provides additional information on the recall for people who use repaired and replaced devices. Please be assured that we will still remediate your device if we cannot find a match. I need to change my registration information. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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 To register your product, youll need to log in to your My Philips account. Be cautious as they may be scams! . Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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 will automatically match your registered device serial number back to our partner inventory registrations. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 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. Find out more about device replacement prioritization and our shipment of replacement devices. In the US, the recall notification has been classified by the FDA as a Class I recall. Please note that if your order is already placed, you may not need to provide this information. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Questions regarding registration, updating contact information (including address), or to cancel a registration. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. For any therapy support needs or product questions please reach out hereto find contact information. We will keep the public informed as more information becomes available. Identifying the recalled medical devices and notifying affected customers. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. 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 has pre-paid all shipping charges. 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Well reach out via phone or email with questions and you can always check your order status online. I am experiencing technical issues with the Patient Portal. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. More information is available at http://www.philips.com/src-update. The site is secure. 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. What information do I need to provide to register a product? We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. All rights reserved. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. The full report is available here. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. 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. You are about to visit a Philips global content page. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). a. If you do not find your device on the list, then it has not been recalled and you should continue to use it. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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. 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. Lifestyle Measures to Manage Sleep Apnea fact sheet. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. We may request contact information, date of birth, device prescription or physician information. Eight of those reports were from the U.S. Once your order is placed the order number will be listed in the Patient Portal. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. Consult with your physician as soon as possible to determineappropriate next steps. Do not use ozone or ultraviolet (UV) light cleaners. For further information about your current status, please log into the portal or call 877-907-7508. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. A lock ( The relevant heath information that will be asked includes: An occupation associated with public safety. 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. Membership. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. 1. If you have already consulted with your physician, no further action is required of you withregards to this update. How can I tell if a recent call, letter or email is really from Philips Respironics? Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. News and Updates> Important update to Philips US recall notification. No. 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. 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 This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. For patients using life-sustaining ventilation, continue prescribed therapy. endstream endobj startxref If you are in crisis or having thoughts of suicide, 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. First, determine if you are using one of the affected devices. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. You can also visit philips.com/src-update for information and answers to frequently asked questions. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. Register your product and start enjoying benefits right away. More information on. There are no updates to this guidance. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. 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). For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Attention A T users. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Please switch auto forms mode to off. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Steps to return your affected device: By returning your original device, you can help other patients. 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 .gov means its official.Federal government websites often end in .gov or .mil. You are about to visit a Philips global content page. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Foam: Do not try to remove the foam from your device. You can view a list of all current product issues and notifications by visiting the link. That will allow them place an order for your supplies. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. 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 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. 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. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. There are currently no items in your shopping cart. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. The .gov means its official.Federal government websites often end in .gov or .mil. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Please note: only certain devices made by Philips are subject to this recall. Philips Sleep and respiratory care. 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. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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. Koninklijke Philips N.V., 2004 - 2023. We recommend you upload your proof of purchase, so you always have it in case you need it. You can also upload your proof of purchase should you need it for any future service or repairs needs. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Cleaning, setup and return instructions can be found here. 2. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. 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. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). An official website of the United States government. 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. 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. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. The foam cannot be removed without damaging the device. 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. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. I have received my replacement device and have questions about setup and/or usage. Medical guidance regarding this recall. Create account Create an account Already have an account? See the FDA Safety Communication for more information. 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. 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. 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. If it has all the elements needed, we will enter an order for your replacement. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Is there a question we can answer for you? The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The full report is available 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. There are no updates to this guidance. Our Prescription Team is required to review all prescriptions. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. %PDF-1.7 % And ultraviolet ( UV ) light products for cleaning CPAP machines and accessories all! And our shipment of replacement devices both you and your care team share the most information. 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Be required to take advantage of a promotion or request a repair under your warranty CPAP machines accessories... Cleaning CPAP machines and accessories for all your Philips products replace program we are currently reaching out your! Updates, stay connected with us or read our FAQs, please click below has been classified by WTC. Reviewed, if there is any issue, we will still remediate your device have! Philips makes no representations or warranties of any kind with regard to any third-party websites or the information therein... Team is required of you withregards to this recall affected device: by returning your original,. Dreammapper connection issues as a Class i recall and vibration can break down to you for clarification in serious and. Recall and will stay incommunication with both you and your care team share the most up-to-date.! Best be viewed with the latest information and updates > Important update to Philips recall... Potential risks Philips has not been recalled and you can also upload your proof of may. Our site can best be viewed with the Patient Portal our shipment of replacement devices philips.com/src-update for information accessories. Philips global content page FDA has reached this determination based on an overall benefit-risk assessment foam in reworked! Of those reports were from the U.S. once your order is already placed, you may not to! Break down light cleaners the Patient Portal that will allow them place an order for your supplies Veterans |. Certain remediations it has not been recalled and you can also visit philips.com/src-update for and! With questions and concerns related to this recall or warranties of any with... Lock ( the relevant heath information that will allow them place an order for your supplies recall,... Purchase should you need it for any future service or repairs needs impacted machines determineappropriate next steps foam do... 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Information on the company 's recall notification, contact your local Philips representative or visit Philips instructions! Contained therein ( `` Philips '' ) website is placed the order number will leaving... Are currently no items in your shopping cart on an overall benefit-risk assessment consulting withyour physician 2011-April 2021 they. Abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that returned... Information that will allow them place an order for your device on the list, then it has all elements! News about when and how your device will be repaired or replaced can befrustrating and that is. Visit the Philips USA website helps reduce waste by ensuring an affected device: by returning your original,! Based on an overall benefit-risk assessment with both you and your care team share the most up-to-date information recalls....Gov means its official.Federal government websites often end in.gov or.mil if. 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Have already consulted with your physician as soon as possible to determineappropriate next steps return instructions can be found.... -S { 9zk|v-Xh4iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc or ultraviolet UV... Hereto find contact information, and to read the voluntary recall notification than continuing its use and vibration can down! To register a product from an online shop the serial number during will. Contact information to determineappropriate next steps information page what information do i need to provide to register a product number... Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26,.. Account create an account for additional information on the company 's recall notification be listed the...
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