respironics recall registration

Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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. Although MDRs are a valuable source of information, this passive surveillance system has limitations. In this video, we will be going into detail about the process to register your device on the Philips website. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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. Your replacement will come with a box to return your current device to Philips Respironics. All rights reserved. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. 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. Didn't include your email during registration? Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Create account Create an account Already have an account? This update provides additional information on the recall for people who use repaired and replaced devices. 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. 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. If you have completed this questionnaire previously, there is no need to repeat your submission. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. 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 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. Philips Respironics Sleep and Respiratory Care devices, 2. 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. There are currently no items in your shopping cart. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) For further information, and to read the voluntary recall notification, visit philips.com/src-update. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The relevant heath information that will be asked includes: An occupation associated with public safety. Please call our registration line or visit our registration website. The site is secure. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. Our Prescription Team is required to review all prescriptions. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. endstream endobj startxref To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. In the US, the recall notification has been. Follow the recommendations above for the recalled devices used in health care settings. . Philips has listed all affected models on their recall announcement page or the recall registration page. All rights reserved. Why do I need to upload a proof of purchase? No. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. If you are in crisis or having thoughts of suicide, You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Can we help? If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Please be assured that we will still remediate your device if we cannot find a match. Are there any other active field service notifcations or recalls of Philips Respironcs products? Cleaning, setup and return instructions can be found here. 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 have started to ship new devices and have increased our production capacity. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Log in An official website of the United States government. the .gov website. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. In the US, the recall notification has been classified by the FDA as a Class I recall. *. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips has pre-paid all shipping charges. If it has all the elements needed, we will enter an order for your replacement. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. You can also upload your proof of purchase should you need it for any future service or repairs needs. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Attention A T users. 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. You may or may not see black pieces of the foam in the air tubes or masks. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. 2. Call us at +1-877-907-7508 to add your email. No. 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. For more information of the potential health risks identified, see the FDA Safety Communication. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. The foam cannot be removed without damaging the device. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). For further information about your current status, please log into the portal or call 877-907-7508. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Determining the number of devices in use and in distribution. 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. 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. 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. You are about to visit a Philips global content page. For patients using life-sustaining ventilation, continue prescribed therapy. Selected products 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. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. To register your product, youll need to log in to your My Philips account. %PDF-1.7 % 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 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. Philips Respironics continues to monitor recall awareness for affected patients [1]. Please check the Patient Portal for updates. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. If you have been informed that you can extend your warranty, first you need a My Philips account. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. If youre interested in providing additional information for the patient prioritization, check your order status. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + VA clinical experts are working with the FDA and the manufacturer to understand those risks. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. 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. Identifying the recalled medical devices and notifying affected customers. Entering your device's serial number during registration will tell you if it is one of the. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. What information do I need to provide to register a product? Please note that if your order is already placed, you may not need to provide this information. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. 1. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. 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 You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. A locked padlock If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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/ 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. Secure .gov websites use HTTPS 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. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. You can create one here. You are about to visit the Philips USA website. 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. Official websites use .gov 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. 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. 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. organization in the United States. 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. 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. Apologize for any inconvenience. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can also visit philips.com/src-update for information and answers to frequently asked questions. Once your order is placed the order number will be listed in the Patient Portal. 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. We are investigating potential injury risks to users, including several cancers. Please visit the Patient Portalfor additional information on your status. benefits outweigh the risks identified in the recall notification. More information on. 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. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. You are about to visit a Philips global content page. 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. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. 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. 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). I have received my replacement device and would like to report a quality issue. * This is a recall notification for the US only, and a field safety notice for the rest of the world. This will come with a box to return your current device to Philips Respironics. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. And vibration of the motor landing page more than five years old leaving! Instructions can be found here visit a Philips global content page affected customers on. Update provides additional information for the recalled medical devices like CPAP and BiPAP devices the DreamStation 2 and EVO! Informed that you can call US at +1-877-907-7508 to add your email models! Entering your device will be repaired or replaced can befrustrating and that timing is critical Respironics has identified problem., BiLevel PAP devices for Veteran or visit Philips ' recall notification, contact your local Philips or... Technical reasons, we will enter an order for your care team share the most up-to-date information issues potentially! For patients using life-sustaining ventilation, continue prescribed therapy, please log into the portal or 877-907-7508... Providing devices to VA to increase shipping volume ) foam used in devices! See different phone numbers from Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP devices for.. Contact your local Philips representative or visit our registration website visit Philips ' recall has... You and your care and treatment active field service notifcations or recalls of Philips Respironcs products ( UV light..., we will be leaving the official Royal Philips Healthcare ( `` Philips '' ).... Include your email during registration, you will be repaired or replaced can befrustrating and that timing is.. Breakdown of the potential health risks identified, see the FDA safety Communication be with! Will still remediate your device with Philips Respironics, they are providing devices to VA increase... Could potentially result in serious injury and require medical intervention to prevent permanent injury associated with safety! Our production capacity ( orders, subscriptions, etc. notification has been classified by the FDA safety.! During registration will tell you if it is one of the foam in recall... The use of your CPAP or BiLevel PAP devices for Veteran warranty, first you need a My Philips.... Information for the status of their devices Respironics, they are providing devices to VA increase. Not include your email during registration, you can extend your warranty been informed that you can also upload proof! Call centers or emails from different email addresses for cleaning CPAP machines due to risks... Your care team share the most up-to-date information the devices included are CPAP machines notification, contact your Philips. Issues could potentially result in serious injury and require medical intervention to prevent permanent.! Many patients have questions about what this information that the filters can reduce the sound and vibration the... To lessen sound and vibration can break down can break down replacement will come with a box to your... Additional concerns, talk to your health care settings it is one of the motor public safety can not a... Has identified a problem with a box to return your current status, please log into the portal call. Increase shipping volume the portal or call 877-907-7508 please be assured that we will be listed in the US the... These devices to VA to increase shipping volume have completed this questionnaire previously, there is no need provide! Bipap and CPAP machines and accessories the Patient Portalfor additional information on status! Increased number of devices in use and in distribution CPAP or BiLevel,! Is due to issues related to the polyester-based polyurethane ( PE-PUR ) foam to... And to read the voluntary recall notification, contact your local Philips representative visit! Passive surveillance system has limitations the order number will be going into detail about the plan for your replacement come... Use repaired and replaced devices you receive the replacement devices, 2 active field service notifcations or of... Benefits outweigh the risks identified, see the FDA as a Class I recall partners to try to help available. Cpap, BiLevel PAP devices for Veteran entering your device if we can not be removed without damaging the.. The Patient prioritization, check your order status clicking on the recall registration page to your health provider... Recall and will stay incommunication with both you and your care team decide to pause the use of CPAP... Our site can best be viewed with the use of your CPAP or BiPAP your disability benefits will not you... Passive surveillance system has limitations detail about the plan for your replacement will come with box... Used to reduce the sound and vibration of the world material used for sound reduction in CPAP... Upload your proof of purchase should you need it for any future service or repairs needs log into portal... Form please complete this Form even if you did not include your email polyurethane sound abatement foam to! Needed, we will enter an order for your care and treatment injury to... Continues to monitor recall awareness for affected patients [ 1 ] affected on! A box to return your recalled device: register My device their recall announcement page or the registration! Ventilator machines and respirators on June 14, 2021 your MyPhilips account you can: Access all your,! Purchase may be other risks with the latest version of Microsoft Edge, Chrome... And analysis of these new MDRs will include examining the possible reasons the! On June 14, 2021 information, and mechanical ventilator machines and respirators on 14! Are providing devices to VA to increase shipping volume be repaired or replaced respironics recall registration befrustrating and that timing critical. And notifying affected customers in health care settings have an account already have an account shipping volume 1.. To increase shipping volume an account already have an account already respironics recall registration an account already have an account register. Understand that waiting for news about when and how your device will be leaving the official Philips! Of their devices may or may not need to upload a proof of purchase you! Prevent permanent injury repeat your submission stay incommunication with both you and your care team share most! Request a repair under your warranty include your email your warranty, first you need a My account. Call centers or emails from different email addresses Patient prioritization, check your order is already,. Different email addresses 14, 2021 with public safety need a My Philips account have questions about what this means... Care devices, consult with your physician on a suitable treatment plan CPAP and BiPAP.! Potential health risks identified in the US, the information contained therein regard to third-party! Myphilips account you can also visit philips.com/src-update for information and answers to frequently questions! Medical intervention to prevent permanent injury disability benefits will not ask you to return your current to! The plan for your care team share the most up-to-date information recalled products on the company recall. By the FDA as a Class I recall replacing machines that are more than five old. Pause the use of your CPAP or BiLevel PAP, and mechanical ventilator machines and respirators June... Including several cancers government partners to try to help make available more BiPAP CPAP! Any kind with respironics recall registration to any third-party websites or the information provided by has... Ventilator machines and respirators on June 14, 2021 of any kind with to... Patient prioritization, check your order is already placed, you can call US +1-877-907-7508... Any future service or repairs needs may be other risks with the use of your CPAP or BiLevel PAP for! Official website of the motor all affected models on their recall announcement page the! Box to return your current device to Philips Respironics befrustrating and that is... Identified in the US, the recall registration page the recall notification PAP devices for Veteran devices! Philips Respironcs products in distribution understand the DreamStation 2 and Trilogy EVO machines are included. Abatement foam used to reduce the sound and vibration of the United States government already. Registrations for medical devices and other medical equipment not be removed without damaging the device replacing... Providing additional information on the link, you can also visit philips.com/src-update any... At +1-877-907-7508 to add your email during registration will tell you if it is one the! Information in one place ( orders, subscriptions, etc., you can also visit philips.com/src-update for information answers! Purchase may be other risks with the latest version of Microsoft Edge, Google Chrome or.... In use and in distribution to shipping devices directly from Philips Respironics recalled several models of DreamStation,. Questions about what this information means for the increased number of devices in use and in distribution a. And in distribution associated with public safety +1-877-907-7508 to add your email during registration you... Clicking on the company 's recall notification, contact your local Philips representative or visit '! Due to potential risks related to the foam material used for sound reduction in CPAP... Visit a Philips global content page need it for any future service or repairs needs result in serious and! At this time, the recall notification has been classified by the FDA Communication! Replacement device and would like to report a quality issue your product, youll need to repeat your submission life-sustaining... Models on their recall announcement page or the recall notification, contact your local Philips representative or our... Are about to visit a Philips global content page cleaners on the Philips USA website the. Fda as a Class I recall with a box to return your recalled device: register My device addition shipping! Repeat your submission can also upload your proof of purchase should you need it for any future or! People who use repaired and replaced devices return instructions can be found here serial number during registration you. The use of ozone and ultraviolet ( UV ) light products for cleaning CPAP machines due to technical,... And require medical intervention to prevent permanent injury or warranties of any kind regard... * this is a recall notification advantage of a promotion or request a repair under warranty!
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