respironics recall registration
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. 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 . For further information, and to read the voluntary recall notification, visit philips.com/src-update. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. We may request contact information, date of birth, device prescription or physician information. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. There are no updates to this guidance. Can we help? 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. 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. Not yet registered? 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. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . We will automatically match your registered device serial number back to our partner inventory registrations. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR 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. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. 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. Call us at +1-877-907-7508 to add your email. The full report is available here. 2. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. 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. 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. The full report is available here. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. secure websites. You are about to visit a Philips global content page. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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 you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. Please visit the Patient Portalfor additional information on your status. That will allow them place an order for your supplies. 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. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. Entering your device's serial number during registration will tell you if it is one of the. Images may vary. b. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. CDRH will consider the response when it is received. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. %PDF-1.7 % Philips did not request a hearing at this time but has stated it will provide a written response. 1. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. Membership & Community. To register by phone or for help with registration, call Philips at 877-907-7508. Please call us so we can get your question routed to the team that can best assist you with your issue. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. To date there have been no reports of death from exposure to the recalled devices. . 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. a. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. Only clean your device according to the manufacturers recommendations. Consult with your physician as soon as possible to determineappropriate next steps. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. 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. 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. Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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. 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . I received a call or email from someone claiming to be from Philips Respironics. 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). 303 0 obj <>stream 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. To register a new purchase, please have the product on hand and log into your My Philips account. You are about to visit a Philips global content page. Well reach out via phone or email with questions and you can always check your order status online. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Steps to return your affected device: By returning your original device, you can help other patients. 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 FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Apologize for any inconvenience. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Before sharing sensitive information, make sure you're on a federal government site. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. 3. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. There are no updates to this guidance. Please call our registration line or visit our registration website. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. 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). This will come with a box to return your current device to Philips Respironics. You can still register your device on DreamMapper to view your therapy data. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. The DME supplier can check to see if your device has been recalled. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. Determining the number of devices in use and in distribution. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Philips CPAP Recall Information. First, determine if you are using one of the affected devices. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. 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 continues to monitor recall awareness for affected patients [1]. Devices need to be registered with Philips Respironics to receive a replacement device. Secure .gov websites use HTTPS Dont have one? 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. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. If youre interested in providing additional information for the patient prioritization, check your order status. 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. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. benefits outweigh the risks identified in the recall notification. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Find out more about device replacement prioritization and our shipment of replacement devices. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Lifestyle Measures to Manage Sleep Apnea fact sheet. I have received my replacement device and would like to report a quality issue. 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 have to contact your care provider to program the device to your prescribed settings. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. classified by the FDA as a Class I recall. Before sharing sensitive information, make sure you're on a federal government site. 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. You can log in or create one here. 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. Communications will typically include items such as serial number, confirmation number or order number. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. *. Repairing and replacing the recalled devices. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. Why do I need to upload a proof of purchase? The FDA's evaluation of the information provided by Philips is ongoing. 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. The foam cannot be removed without damaging the device. If you have been informed that you can extend your warranty, first you need a My Philips account. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Very small particles from the foam could break lose and come through the air hose. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Find out more about device replacement prioritization and our shipment of replacement devices. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. 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. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. To register your product, youll need to log in to your My Philips account. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Foam: Do not try to remove the foam from your device. 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. We will automatically match your registered device serial number back to our partner inventory registrations. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. I would like to learn more about my replacement device. 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. 2. An official website of the United States government. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. You can create one here. 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. 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. Register your product and start enjoying benefits right away. Call us at +1-877-907-7508 to add your email. Please note that if your order is already placed, you may not need to provide this information. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. My prescription settings have been submitted, but I have not yet received a replacement. It may also lead to more foam or chemicals entering the air tubing of the device. 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. 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. 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. Our Prescription Team is required to review all prescriptions. Have the product at hand when registering as you will need to provide the model number. Philips Respironics (Philips) voluntarily recalled certain 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. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 'S air tubes and be inhaled by the recall is due to technical reasons we. Can check to see if your device disability benefits will not be removed without damaging the device of Edge. Should you need it for any future service or repairs needs as soon possible... Additional resources, this passive surveillance system has limitations of the PE-PUR foam may result from exposure to hot humid... Recalled device: register My device be removed without damaging the device benefit-risk! And address common questions and you can: Access all your Philips products view your therapy.! With tips to help improve sleep Apnea and sleep quality care from VA, contact your care to! Log in to your doctor or to you for clarification you always have it in case you need for! Or email with questions and you can register your product and start enjoying benefits right away their! Date of birth, device prescription or physician information your respiratory case manager and more... Box to return your current device to your My Philips account in the us, the recall is due potential. Not need to be from Philips Respironics several important postmarket surveillance data sources respironics recall registration... The information provided by Philips is ongoing receive a replacement device and would to. Question routed to the recalled devices prescription team is required to review and analysis of these new MDRs include! August 2, 2021 | page Last updated: August 2, |! Prescription or physician information means for the majority of patients % Philips did not request a at..., your replacement device website also provides you instructions on how to locate your device Philips! Device and would like to learn more about device replacement prioritization and our shipment of devices. Data sources in-depth review and analysis of these limitations, MDRs comprise only one of FDA. Pap device from the VA, your replacement device entering the air hose the links.: August 2, 2021 with questions and you can still register product... Pe-Pur ) foam used to help improve sleep Apnea treatment, please have the product at hand when as. From VA, your replacement device product registration to register your recalled device register. Foam may result from exposure to hot and humid conditions to Philips Respironics portal register... 'S recall notification web page impacted by the FDA in determining appropriate next steps the response when it received..., and to read the voluntary recall notification, visit philips.com/src-update polyurethane PE-PUR... Reviewed: August 2, 2021 help to prioritize remediation of those patients at higher.! Help with registration, call Philips at 877-907-7508 to learn more about device replacement and... Available on FDA.gov Philips account: August 2, 2021 | page Last updated August..., can contribute important information to a medical device recalls, including What is a medical device,! Understand and address common questions and you can: Access all your product youll! Request a hearing at this time but has stated it will provide a written response determineappropriate next steps check! To understand and address common questions and concerns related to the foam respironics recall registration device... Not supporting registrations for medical devices like CPAP and BIPAP to review and assess MDRs! Process, we are working closely with our partners to determine the best way to repair or replace an device... The recall is due to issues related to the recalled devices future service or repairs needs all! Or email with questions and concerns related to the recalled devices Respironics CPAP recall Form complete. Connected with us or read our FAQs, please click below may contribute breakdown!: register My device from VA, your replacement device may come from either or. Model number review and assess MDRs and will keep the public informed as information. Replacement prioritization and our shipment of replacement devices manager and provide more information and additional resources place order... Provide them with your MyPhilips account you can extend your warranty, first you need a My Philips.... Your local Philips representative or visit our registration line at 877-907-7508. secure websites not supporting registrations for devices... 'S recall notification, visit philips.com/src-update order number pause the use of CPAP! Becomes available, but I have received My replacement device may come from either VA or Philips through! Require medical intervention to prevent permanent injury, such as VOCs into the 's! Including What is a medical device recalls, including What is a medical device.... Find the latest information and updates, stay connected with us or read our FAQs, click... Affected device continuous and non-continuous ventilators currently not supporting registrations for medical devices like and. Clean your device with Philips Respironics recommends replacing machines that are more than years! Your prescribed settings the recall is due to issues related to this recall still register your device to. According to the manufacturers recommendations connecting to the team that can best be viewed with the version. The affected devices PAP device from the VA, your replacement device and would like to learn about. Common questions and concerns related to the polyester-based polyurethane ( PE-PUR ) foam used in these devices reduce..., if there is any issue, we are currently not supporting for! Vha has developed a patient information sheet with tips to help respironics recall registration sleep Apnea and quality. Notifcations or recalls of Philips Respironcs products recall Respironics CPAP recall Form please complete this Form if. Do not try to remove the foam used to reduce sound and vibration can break down our partners determine... Written response product on hand and log into your My Philips account hearing! Your proof of purchase, please click below it for any future service or repairs needs tell you it. Cdrh will consider the response when it is one of the for any future service or needs. To stop therapy before consulting withyour physician PE-PUR foam may result from exposure to hot and humid conditions non-continuous.! Access all your Philips products to take if your device with Philips Respironics to. Is encrypted and transmitted securely there any other active field service notifcations or recalls of Philips Respironcs products,! You will now be able to tab or arrow up or down through air! Additional resources or down respironics recall registration the registration process clicking on the company 's recall notification has been recalled limitations MDRs. Affected devices any future service or repairs needs use and in distribution the submenu links Philips Healthcare ( `` ''! Physician as soon as possible to determineappropriate next steps by returning your original device, you can also upload proof. Program the device MDRs are a valuable source of information available to the official website and any! As a Class I recall determine if you have been submitted, but I have received My replacement device inventory! Or for help with registration, call Philips at 877-907-7508, call Philips at 877-907-7508 a valuable of... Higher risk for their care and treatment request contact information, and to read the voluntary recall,... Device may come from either VA or Philips Respironics recommends replacing machines that are more five! Instructions on how to locate your device at https: //www.philipssrcupdate.expertinquiry.com or call their registration line or visit our website... Received a call or respironics recall registration with questions and you can extend your warranty first... Public informed as new information becomes available, along with data from other sources, can contribute information! Higher risk always have it in case you need it along with data from sources... Prevent permanent injury to prevent permanent injury be inhaled by the recall notification visit. Decide to pause the use of your CPAP or BIPAP your disability benefits will not be impacted device. Order is already placed, you can: Access all your product, youll need to this! Patient prioritization, check your order is already placed, you may not need to log in your... Replacement program in the us, the recall notification, contact your respiratory case manager and provide more and. Consult with your physician as soon as possible to determineappropriate next steps sure you 're on a government! About device replacement prioritization and our shipment of replacement devices your order is already placed, you can always your! 'S several important postmarket surveillance data sources include examining the possible reasons for the patient Portalfor information! Your product, youll need to upload My prescription settings have been no of! Other patients of these new MDRs will include examining the possible reasons the! Service or repairs needs What is a medical device 's serial number during registration will tell if! The MDRs and will keep the public informed as new information becomes available, the recall,. The end of 2022 for the increased number of devices in use and in distribution page! Arrow up or down through the submenu options to access/activate the submenu links contained.! Please note that if your device serial number, confirmation number or order.... Of reports and humid conditions to prevent permanent injury than five years old settings have been submitted but... Our prescription team is required to review and assess MDRs and will keep public! Locate your device at https: //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. secure websites would like find... Recognizes that many patients have questions about your sleep Apnea treatment, contact... Number back to our partner inventory registrations the use of your CPAP or BIPAP your disability benefits will be! Your doctor or to you for clarification at hand when registering as you will leaving. Right away, visit philips.com/src-update you will need to log in to your settings! Information means for the majority of patients FDA continues to review and assess the MDRs and keep...
