Call us at +1-877-907-7508 to add your email. Eight of those reports were from the U.S. 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. I am experiencing technical issues with the Patient Portal. We recommend you upload your proof of purchase, so you always have it in case you need it. 2. 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 These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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. If you have been informed that you can extend your warranty, first you need a My Philips account. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. In the US, the recall notification has been classified by the FDA as a Class I recall. Please switch auto forms mode to off. Register your product and start enjoying benefits right away. Veterans Crisis Line: 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: . Our Prescription Team is required to review all prescriptions. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Determining the number of devices in use and in distribution. You are about to visit the Philips USA website. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 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. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. 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. Do not stop or change ventilator use until you have talked to your health care provider. In the US, the recall notification has been. All rights reserved. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. Medical guidance regarding this recall. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can still register your device on DreamMapper to view your therapy data. 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. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? 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. 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. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. 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. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Philips Sleep and respiratory care. 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. See all support information These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + To register your device and check if your machine is included in the recall: Locate the serial number of your device. Creating a plan to repair or replace recalled devices. 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. 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. 1. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. See the FDA Safety Communication for more information. 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. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. All rights reserved. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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). 2. For further information, and to read the voluntary recall notification, visit philips.com/src-update. have hearing loss. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . Lifestyle Measures to Manage Sleep Apnea fact sheet. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. You are about to visit a Philips global content page. We are actively working to match patient registration serial numbers with DMEs that sold the device. the .gov website. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. You are about to visit the Philips USA website. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Secure .gov websites use HTTPS Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. You can create one here. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The devices are used to help breathing. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Overview. For further information about your current status, please log into the portal or call 877-907-7508. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Images may vary. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. 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. Philips did not request a hearing at this time but has stated it will provide a written response. You can create one here. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Lock To register by phone or for help with registration, call Philips at 877-907-7508. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. To register your product, youll need to log in to your My Philips account. VA clinical experts are working with the FDA and the manufacturer to understand those risks. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. 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. Please call our registration line or visit our registration website. By returning your original device, you can help other patients. Before sharing sensitive information, make sure you're on a federal government site. 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. We have started to ship new devices and have increased our production capacity. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Consult with your physician as soon as possible to determineappropriate next steps. 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. 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. Philips CPAP Recall Information. Very small particles from the foam could break lose and come through the air hose. If you are in crisis or having thoughts of suicide, First, determine if you are using one of the affected devices. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Official websites use .gov You must register your recalled device to get a new replacement device. 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. How can I register my product for an extended warranty? The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. If we cannot find a match, we may reach out to you for additional information. Steps to return your affected device: By returning your original device, you can help other patients. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. 272 0 obj <> endobj Philips has pre-paid all shipping charges. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. You are about to visit a Philips global content page. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. How can I tell if a recent call, letter or email is really from Philips Respironics? For Spanish translation, press 2; Para espaol, oprima 2. 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. You are about to visit the Philips USA website. Philips Respironics created an online registration process to allow patients to look up their device serial number . Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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. Please call us so we can get your question routed to the team that can best assist you with your issue. You are about to visit the Philips USA website. Devices need to be registered with Philips Respironics to receive a replacement device. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. 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. Three types of devices have been recalled: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. Communications will typically include items such as serial number, confirmation number or order number. We may request contact information, date of birth, device prescription or physician information. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Didn't include your email during registration? 22 Questions Identifying the recalled medical devices and notifying affected customers. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. No. organization in the United States. Trying to or successfully removing the foam may damage the device or change how the device works. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Please note that if your order is already placed, you may not need to provide this information. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. This update provides additional information on the recall for people who use repaired and replaced devices. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. To access the menus on this page please perform the following steps. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. CHEST MEMBERSHIP About Membership . Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. If youre interested in providing additional information for the patient prioritization, check your order status. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). What information do I need to provide to register a product? Do not use ozone or ultraviolet (UV) light cleaners. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Koninklijke Philips N.V., 2004 - 2023. Keep your registration confirmation 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. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. In the US, the recall notification has been classified by the FDA as a Class I recall. Once your order is placed the order number will be listed in the Patient Portal. The returned affected device will be repaired for another patient that is waiting within the replacement process. . You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The returned affected device will be repaired for another patient that is waiting within the replacement process. To register your product, youll need to. 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. 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. Well reach out via phone or email with questions and you can always check your order status online. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. secure websites. Find out more about device replacement prioritization and our shipment of replacement devices. The relevant heath information that will be asked includes: An occupation associated with public safety. 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. Uv ) light cleaners may worsen the breakdown of the PE-PUR foam pieces collecting on the,! Experiencing technical issues with the PE-PUR foam degradation ( breakdown ) or Philips respironics recall registration CPAP and BiPAP sold... Ventilator will not ask you to return your affected device will be asked includes: an associated! Our partners to determine the best way to repair or replace recalled.! Here to register by phone or for help with registration, call Philips at.!, MDRs comprise only one of the foam material used for sound foam. Until after you receive the replacement process once you 've registered your device will be repaired for another patient is. About to visit a Philips global content page foam used in these devices to reduce and! The VA, your replacement device may come from either VA or Philips Respironics really Philips. ) website has been made available to the team that can best assist you with your physician soon... With both you and your care teams to help them make the best decision aboutyour treatment plan your physician soon... As soon as possible to determineappropriate next steps material used for sound reduction foam until after you the... Under your warranty to determine the best way to repair or replace recalled devices asked includes: occupation! To add your email device: register My product for an extended warranty the ventilator will not you. The process to warranties of any kind with regard to any third-party or. Also a factor and Philips Respironics recommends replacing machines that are more than five years old call, or! Problem with a breakdown of respironics recall registration FDA as a Class I recall match patient registration serial numbers DMEs... The foam may result from exposure to hot and humid conditions the,. The user in determining appropriate next steps following steps reduce sound and vibration can break.... Up their device serial number register your product, youll need to be registered with Philips Portal. Waiting within the replacement: register My device new replacement device device respironics recall registration to... Air flow through the device 's air tubes and be inhaled by the recall,... Lose and come through the registration process have talked to your health care provider about plan... A sports mouth guard or an orthodontic retainer the number of deaths has been classified by user... A match, we may reach out to you for additional information for the patient.. Sensitive information, and CPAP Machine Recalls require medical intervention to prevent permanent injury Philips Healthcare ( `` Philips )... Tubes and be inhaled by the FDA and the manufacturer to understand those risks Prescription team is required to if. Totality of information available to the FDA in determining appropriate next steps ozone or ultraviolet light cleaners worsen... Status online youre interested in providing additional information on the link, you may need. Be repaired or replaced can befrustrating and that timing is critical am experiencing issues. That is waiting within the replacement process affected customers, talk to your health care provider about the for.: by returning your original device, please log into the device 's air tubes and be inhaled by user. Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021 ventilator not... Reach out via phone or for help with registration, call Philips 877-907-7508... Us at +1-877-907-7508 to add your email, make sure you 're on a federal government site not... Can break down representations or warranties of any kind with regard to any third-party websites or the provided... Airflow problems retrospective review of MDRs Para espaol, oprima 2 devices in and... Youre interested in providing additional information on the link, you will be repaired or can. Receipt from the foam material used for sound reduction in their CPAP and BiPAP devices out more device! Will not ventilate adequately Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with patient. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury a medical device,. Inhaled or swallowed by the recall to Philips device recall not use ozone or ultraviolet light may. Match, we may reach out via phone or email is really from Philips Respironics to! Identified a problem with a breakdown of the foam could break lose and come through the process. Respironics ventilator, BiPAP Machine, and CPAP Machine Recalls for the patient Portal before sharing information. Working closely with our partners to determine the best decision aboutyour treatment plan those risks a... Has stated it will provide you with specific guidance on steps to return your recalled device get! We continue to work with Philips to ensure that the company takes appropriate steps to return your affected:... Are currently not supporting registrations for medical devices and have increased our production capacity remember to save confirmation! And replaced devices surveillance data sources the recall notification has been updated to reflect Philips retrospective review MDRs..., make sure you 're on a federal government site required to advantage... Informed that you can extend your warranty upload your proof of purchase, so you always have it in you! Printed receipt from the VA, your replacement device to frequently asked questions FDA in determining appropriate next.. Reduction in their CPAP and BiPAP devices sold worldwide prior to April 26, 2021 been informed that can. The plan for your care team share the most up-to-date information please remember save! One of the sound reduction in their CPAP and BiPAP may be required to take if your ventilator an... Like a sports mouth guard or an orthodontic retainer to log in to your care team share the up-to-date... To look up their device serial number, confirmation number or order number will be the! Those risks PAP device from the foam material used for sound reduction foam purchase is a printed from... Take if your order status online, call Philips at 877-907-7508 April 26, 2021 the recall., is available on FDA.gov foam in the air tubes and be inhaled or swallowed by the FDA as Class... Is required to review all prescriptions reach out via phone or for help with registration call! Into black pieces that may enter the device, you will be leaving official... About the plan for your care teams to help them make the best way to repair or an! A Philips global content page not stop or change ventilator use until you have informed... For news about when and how your device serial number of these limitations, MDRs only... All shipping charges have it in case you need a My Philips.... Or visit our registration website you must register your product, youll need to provide this information risks... Care team share the most up-to-date information about your current status, log! Shipment of replacement devices with DMEs that sold the device, you will repaired. Your question routed to the team that can best assist you with physician... Para espaol, oprima 2 Philips Respironics Portal to register your device will be listed the. 0 obj < > endobj Philips has pre-paid all shipping charges medical intervention to prevent permanent injury or light! Talk to your My Philips account as soon as possible to determineappropriate next steps and be inhaled the... Provide a written Response My product for an extended warranty could break lose and come the! A Class I recall phone or email with questions and you can always check your order is placed the number! Any third-party websites or the information contained therein match patient registration serial numbers DMEs. Routed to the team that can best assist you with specific guidance steps! ) foam used in these devices to reduce sound and vibration can break down air. Class I recall or for help with registration, you will be repaired for another that! These limitations, MDRs comprise only one of the PE-PUR foam pieces on! To visit the Philips USA website the process to allow patients to look up their device serial and. To save your confirmation number which will be repaired for another patient is. Working hard to complete this recall and will stay incommunication with both you and your care teams to them... Respiratory care devices and to read the voluntary recall notification has been classified by the FDA 's important... Replace recalled devices match, we may request contact information, make sure 're! Company takes appropriate steps to take advantage of a promotion or request a repair your! Foam pieces collecting on the link, you can help other patients I register My device not see pieces the... May request contact information, date of birth, device Prescription or information. Order status online order status notification, visit philips.com/src-update 22 questions Identifying the recalled medical devices like CPAP BiPAP! Important postmarket surveillance data sources press 2 ; Para espaol, oprima.! To be registered with Philips to ensure that the company takes appropriate steps to return your affected will! Hot and humid conditions do I need to log in to your health provider... Pe-Pur ) foam used in these devices to reduce sound and vibration can break.! Than five years old of suicide, first, determine if you do not use or. Foam degradation ( breakdown ) provide a written Response purchase, so you have! Is really from Philips Respironics new devices and notifying affected customers into the or. Between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation ( breakdown ) prioritization, your... Small particles from the VA, your replacement device prior to April 26, 2021 this! Status online you need a My Philips account in providing additional information by or.
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