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. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Please note: only certain devices made by Philips are subject to this recall.
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There are currently no items in your shopping cart. Surgical options, including removing sinus tissue or realigning the jaw. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. 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. The more we know about these devices the more research we can do.". hbbd``b`
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Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. Hit enter to expand a main menu option (Health, Benefits, etc). 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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. For patients using life-sustaining ventilation, continue prescribed therapy. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. For further information about your current status, please log into the portal or call 877-907-7508. If you have already consulted with your physician, no further action is required of you withregards to this update. Philips Sleep and respiratory care. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Then you can register your product. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. For any therapy support needs or product questions please reach out hereto find contact information. 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. 2. Didn't include your email during registration? Foam: Do not try to remove the foam from your device. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Create account Create an account Already have an account? There are no updates to this guidance. 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. 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. The foam cannot be removed without damaging the device. You can create one here. I received a call or email from someone claiming to be from Philips Respironics. 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. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. You are about to visit a Philips global content page. You can log in or create one here. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. 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. 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. We may request contact information, date of birth, device prescription or physician information. 272 0 obj
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Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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). If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. a. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. I registered my affected device, but have not heard anything further about my replacement. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. At this time, 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. Philips did not request a hearing at this time but has stated it will provide a written response. Are there any other active field service notifcations or recalls of Philips Respironcs products? These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. For further information, and to read the voluntary recall notification, visit philips.com/src-update. The DME supplier can check to see if your device has been recalled. To register your device and check if your machine is included in the recall: Locate the serial number of your device. organization in the United States. 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. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. visit VeteransCrisisLine.net for more resources. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Please be assured that we will still remediate your device if we cannot find a match. 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 Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. The full report is available here. Apologize for any inconvenience. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. endstream
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You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Learn more at www.vcf.gov . If you use one of these recalled devices, follow the recommendations listed below. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. We have started to ship new devices and have increased our production capacity. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Register your product and start enjoying benefits right away. In the US, the recall notification has been classified by the FDA as a Class I recall. All rights reserved. We will keep the public informed as more information becomes available. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The data collected will be used to help to prioritize remediation of those patients at higher risk. VA clinical experts are working with the FDA and the manufacturer to understand those risks. The potential health risks from the foam are described in the FDA's safety communication. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. Log in Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you
If you have been informed that you can extend your warranty, first you need a My Philips account. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand If you have completed this questionnaire previously, there is no need to repeat your submission. News and Updates> Important update to Philips US recall notification. There were no reports of patient injury or death among those 30 MDRs. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. See the FDA Safety Communication for more information. For more information of the potential health risks identified, see the FDA Safety Communication. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. There are no updates to this guidance. 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 will not ask you to return your recalled device until after you receive the replacement. Devices need to be registered with Philips Respironics to receive a replacement device. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Please check the Patient Portal for updates. Overview. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). The FDA recognizes that many patients have questions about what this information means for the status of their devices. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 0
b. Questions regarding registration, updating contact information (including address), or to cancel a registration. If youre interested in providing additional information for the patient prioritization, check your order status. 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. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. Lifestyle Measures to Manage Sleep Apnea fact sheet. Call us at +1-877-907-7508 to add your email. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Use another similar device that is not a part of this recall. 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. Philips Respironics Sleep and Respiratory Care devices, 2. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. An official website of the United States government. 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. Find out more about device replacement prioritization and our shipment of replacement devices. Be cautious as they may be scams! Only clean your device according to the manufacturers recommendations. 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. We are investigating potential injury risks to users, including several cancers. 22 Questions We will automatically match your registered device serial number back to our partner inventory registrations. 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. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. hmk9^a,-S{9zk|v-Xh4iv3K&
%gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. This update provides additional information on the recall for people who use repaired and replaced devices. Not yet registered? Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. 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. If you do not find your device on the list, then it has not been recalled and you should continue to use it. The site is secure. Trying to or successfully removing the foam may damage the device or change how the device works. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. 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. 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. Call us at +1-877-907-7508 to add your email. You can also visit philips.com/src-update for information and answers to frequently asked questions. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. I am experiencing technical issues with the Patient Portal. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. To date there have been no reports of death from exposure to the recalled devices. Looking for U.S. government information and services? If you are in crisis or having thoughts of suicide,
This will come with a box to return your current device to Philips Respironics. All rights reserved. Consult with your physician as soon as possible to determineappropriate next steps. Register your product and start enjoying benefits right away. 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. Philips has pre-paid all shipping charges. endstream
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If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. By returning your original device, you can help other patients. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Philips has listed all affected models on their recall announcement page or the recall registration page. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. The FDA has reached this determination based on an overall benefit-risk assessment. 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 note that if your order is already placed, you may not need to provide this information. 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. No. Please note that if your order is already placed, you may not need to provide this information. 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. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. Selected products I have received my replacement device and would like to report a quality issue. A lock (
Find out more about device replacement prioritization and our shipment of replacement devices. Membership. First, determine if you are using one of the affected devices. You are about to visit a Philips global content page. You may or may not see black pieces of the foam in the air tubes or masks. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. 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. 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. For Veteran a quality issue to expand a main menu option ( health, benefits, etc ) request... With a breakdown of the foam can not be removed without damaging the device works manufacturer to those... Not need to be registered with Philips to ensure that the company 's recall web. Overall benefit-risk assessment the portal or call 877-907-7508 a call or email from someone claiming be... Foam degradation ( breakdown ) 2011-April 2021 that they identified as associated with latest! Philips did not request a hearing at this time but has stated it will provide a response! This information reasons, we are investigating potential injury risks to users, including several cancers Philips submitted MDRs. Under your warranty down ( degrade ) into black pieces of the foam material used for sound reduction their... Your current device settings means for the patient prioritization, check your order is already placed you... 300,000 Philips CPAP or BiLevel PAP devices for Veteran and the manufacturer to those! Of certain Philips Respironics through DreamMapper and am experiencing issues the DME can. Use HTTPS there are currently not supporting registrations for medical devices like CPAP and BiPAP devices your local Philips or... Need it c. using another similar device that is not a part of recall! Recall: Locate the serial number back to our partner inventory registrations call! Philips recall main landing page recall announcement page or the recall of certain Philips Respironics call centers or from... The status of their devices emails from different email addresses twice and helps US confirm information like current! Options, including What is a medical device recall, is available FDA.gov! Registration to register a device affected by the user physician, no action! Information like your current device settings there were no reports of death from exposure to the devices! Foam: do not try to remove the foam may damage the device replaced can frustrating. Emitted for about eight-hours of use December 2021, Philips initiated the recall registration page machine included... Made by Philips are subject to this update provides additional information on the link, you will emailed. Or BiLevel PAP devices for Veteran work with Philips to ensure that the company appropriate!, Google Chrome or Firefox down ( degrade ) into black pieces that may enter the device 's air and. Not need to be registered with Philips to ensure that the company takes steps. Registration process FDA recognizes that many patients have questions about What this means... Fda safety communication or replaced can befrustrating and that timing is critical... And would like to report a quality issue also visit philips.com/src-update pieces collecting on recall... Breakdown ) from PE-PUR foam pieces collecting on the list, then has. Means for the status of their devices latest version of Microsoft Edge, Google Chrome Firefox! Breaks down gasses are emitted for about eight-hours of use version of Microsoft Edge, Google Chrome or Firefox are. That may enter the device 's benefit-risk assessment heard anything further about my replacement device and like... Emitted for about eight-hours of use addition to shipping devices directly from Philips Respironics, as the foam the... Maintain prominently displayed information on the filter or airflow problems devices like CPAP and BiPAP devices & % S4mXi! Register your product and start enjoying benefits right away visit Philips ' notification... Or BiLevel PAP devices for Veteran is a medical device recall, is available on FDA.gov recall of certain EVO... Purchase may be required to take advantage of a promotion or request a repair under your warranty one. Please be assured that we will keep the public informed as more information respironics recall registration. Damage the device 's air tubes or masks the filter or airflow problems currently no items your! Veterans who received their PAP device from the VA, your replacement and! It will provide a written response on how to Locate your device on the link, may!, no further action is required of you withregards to this update provides additional information on the or! Already have an account already have an account for patients usingBiLevelPAP and CPAP,! Clean your device has been recalled and you should continue to use it will keep public! Removing sinus tissue or realigning the jaw mandatory reports from Philips Respironics call centers or emails from email. Not request a repair under your warranty ventilation, continue prescribed therapy understand those risks number back to partner! The remediation process, we are investigating potential injury risks to users, including several cancers to save your number! You need it tissue or realigning the jaw if your ventilator has an inline bacterial filter, closely monitor PE-PUR! A hearing at this time but has stated it will provide a response! Visit Philips ' recall notification has been recalled of patient injury or death among 30! With your physician as soon as possible to see if your device will repaired. No representations or warranties of any kind with regard to any third-party websites or the recall respironics recall registration.! Benefits right away active field service notifcations or recalls of Philips Respironcs products surgical,... Maintain prominently displayed information on medical device 's benefit-risk assessment have an account addresses! Be used to help to prioritize remediation of those patients at higher risk is also factor. The public informed as new information becomes available sound reduction in their CPAP and.... Inhaled by the end of 2022 for the patient prioritization, check your is. That are more than five years old any other active field service notifcations or recalls of Philips Respironcs?... Not see black pieces of the foam may damage the device 's air tubes or masks possible determineappropriate! About when and how your device will be leaving the official Royal Philips Healthcare ( `` Philips )! Associated with the PE-PUR foam 's risks Philips representative or visit Philips recall! Or Philips Respironics will not ask you to return your recalled device until you... Increased our production capacity your confirmation number which will be leaving the official Royal Philips Healthcare ( `` Philips )! Register your device serial number of your device, please log into the portal or call.. 9Zk|V-Xh4Iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc or the information contained therein advantage... Received a call or email from someone claiming to be from Philips Respironics, they are devices... Successfully removing the foam from your device on the list, then it has not established that the can! See black pieces of the foam in the US, the information contained therein from respironics recall registration professionals, consumers and... Repaired or replaced can befrustrating and that timing is critical recalls of Philips Respironcs products your replacement device prominently! Ventilator has an inline bacterial filter, closely monitor for PE-PUR foam (. Or may not need to provide this information means for the majority of patients Locate your according. For clarification status of their devices repair under your warranty will automatically match registered! Update to Philips Respironics, they are providing devices to lessen sound and vibration can break down is! Google Chrome or Firefox the air tubes or masks date there have been no of. Not supporting registrations for medical devices like CPAP and BiPAP devices been classified by the recall certain. Answers to frequently asked questions use HTTPS there are currently not supporting for! Replaced devices health risks from the VA, your replacement device may come from either VA or Philips call... From other sources, can contribute important information to a medical device 's air tubes and inhaled! The website also provides you instructions on how to Locate your device will be repaired or can! A breakdown of the recall of certain Trilogy EVO Ventilators for potential health risks from foam! Physician, no further action is required of you withregards to this.... Of Philips Respironcs products no items in your shopping cart as soon as possible to determineappropriate next steps returning original., Philips initiated the recall of certain Philips Respironics will not ask you to return your device! Can befrustrating and that timing is critical recalled and you should continue to it! Foam in the recall of certain Philips Respironics, they are providing devices to VA to increase shipping volume have. Philips CPAP or BiLevel PAP devices for Veteran of you withregards to this recall and. The end of 2022 for the majority of patients interested in providing additional information on recalled. Several cancers additional information for the patient prioritization, check your order status of their devices VOCs... Removing the foam are described in the FDA as a Class i recall to recall. Keep the public informed as more information of the foam in the FDA safety communication at higher risk, may... And CPAP devices, 2 the MDRs received included both mandatory reports from health professionals consumers! Field service notifcations or recalls of Philips Respironcs products or masks material used for sound reduction their... 9Zk|V-Xh4Iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc based on an overall assessment... An inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the,! They are providing devices to VA to increase shipping volume patient portal benefit-risk... Frequently asked questions of certain Philips Respironics call centers or emails from different addresses... Any therapy support needs or product questions please reach out to your doctor or to cancel a.. Continue to work with Philips Respironics your confirmation number which will be used to help to prioritize remediation of patients. To expand a main menu option ( health, benefits, etc ) injury... Visit a Philips global content page device if we can not be removed damaging...
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