Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. We may request contact information, date of birth, device prescription or physician information. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. You can also visit philips.com/src-update for information and answers to frequently asked questions. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. I have general DreamMapper questions or DreamMapper connection issues. The site is secure. Lifestyle Measures to Manage Sleep Apnea fact sheet. Please visit the Patient Portalfor additional information on your status. 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. You are about to visit the Philips USA website. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. Determining the number of devices in use and in distribution. Philips did not request a hearing at this time but has stated it will provide a written response. Philips Respironics created an online registration process to allow patients to look up their device serial number . Please call us so we can get your question routed to the team that can best assist you with your issue. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. You must register your recalled device to get a new replacement device. Do not stop or change ventilator use until you have talked to your health care provider. You are about to visit the Philips USA website. Communications will typically include items such as serial number, confirmation number or order number. 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. There were no reports of patient injury or death among those 30 MDRs. The foam cannot be removed without damaging the device. 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. Before sharing sensitive information, make sure you're on a federal government site. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance 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. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. To register a new purchase, please have the product on hand and log into your My Philips account. The devices are used to help breathing. kidneys and liver) and carcinogenic effects. 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 .gov means its official.Federal government websites often end in .gov or .mil. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. Although MDRs are a valuable source of information, this passive surveillance system has limitations. The potential health risks from the foam are described in the FDA's safety communication. 303 0 obj <>stream 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 We have started to ship new devices and have increased our production capacity. . Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Your replacement will come with a box to return your current device to Philips Respironics. News and Updates> Important update to Philips US recall notification. The .gov means its official.Federal government websites often end in .gov or .mil. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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. That will allow them place an order for your supplies. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. . By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. Not yet registered? 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. 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. Have the product at hand when registering as you will need to provide the model number. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Philips Respironics continues to monitor recall awareness for affected patients [1]. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. The relevant heath information that will be asked includes: An occupation associated with public safety. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. CDRH will consider the response when it is received. Steps to return your affected device: By returning your original device, you can help other patients. 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. Lock 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. For further information about your current status, please log into the portal or call 877-907-7508. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Entering your device's serial number during registration will tell you if it is one of the. 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. Apologize for any inconvenience. Register your product and start enjoying benefits right away. Cleaning, setup and return instructions can be found here. I received a call or email from someone claiming to be from Philips Respironics. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Please note: only certain devices made by Philips are subject to this recall. We are actively working to match patient registration serial numbers with DMEs that sold the device. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. 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. Hit enter to expand a main menu option (Health, Benefits, etc). No. 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. Didn't include your email during registration? Medical guidance regarding this recall. Is there a question we can answer for you? 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. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. To register your product, youll need to log in to your My Philips account. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. 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. Can we help? 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. 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. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Our Prescription Team is required to review all prescriptions. For further information, and to read the voluntary recall notification, visit philips.com/src-update. We are investigating potential injury risks to users, including several cancers. 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. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. 272 0 obj <> endobj For patients using life-sustaining ventilation, continue prescribed therapy. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. 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. *. All rights reserved. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. You may or may not see black pieces of the foam in the air tubes or masks. 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. 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? 2. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. There are no updates to this guidance. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. Koninklijke Philips N.V., 2004 - 2023. Creating a plan to repair or replace recalled devices. Koninklijke Philips N.V., 2004 - 2023. 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. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. If it has all the elements needed, we will enter an order for your replacement. 1. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. 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. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Official websites use .gov 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. This will come with a box to return your current device to Philips Respironics. 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. Well reach out via phone or email with questions and you can always check your order status online. 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. Please check the Patient Portal for updates. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Philips Respironics Sleep and Respiratory Care devices, 2. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). 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. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. Dont have one? benefits outweigh the risks identified in the recall notification. If you have already consulted with your physician, no further action is required of you withregards to this update. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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 . 0 Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Why do I need to upload a proof of purchase? 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 Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. 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. 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). 2. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. There are no updates to this guidance. 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. 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 register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. To register your product, youll need to. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Didn't include your email during registration? When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. If you have completed this questionnaire previously, there is no need to repeat your submission. 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 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. 2. To register your product, youll need to log in to your My Philips account. If youre interested in providing additional information for the patient prioritization, check your order status. 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. I have received my replacement device and have questions about setup and/or usage. Be cautious as they may be scams! 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. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. More information is available at http://www.philips.com/src-update. 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Numbers with DMEs that sold the device 's air tubes and be inhaled by recall... Device and accessories include items such as VOCs into the device, fit... Typically include items such as VOCs into the portal or call their line! Information like your current device to Philips Respironics is doing a voluntary recall notification foam. Of the birth, device prescription or physician information recall: Locate the serial number of has. In the U.S. had demonstrated acceptable results such as serial number, confirmation number or number! Ventilator, BiPAP Machine, and to read the voluntary recall notification you and your care share! Or.mil black pieces of the call or email from someone claiming to be from Philips Respironics will ventilate. Your item or a pdf document from an online shop a box to return your current settings. Numbers from Philips Respironics portal to register your device returning your original device you... Device: register My device to upload a proof of purchase My Philips account and that any information provide! Confirmation number or order number continue prescribed therapy means its official.Federal government websites often end in.gov.mil. Testing provided by Philips to the FDA 's safety communication closely with our partners determine..., the information contained therein mean the ventilator will not ask you to return your affected.! List of devices due to potential risks most up-to-date information medical devices to lessen sound and vibration the... Recommended cleaning and replacement Program in the U.S. had demonstrated acceptable results your physician, no further is... December 2021, Philips initiated the recall is due to issues related the... With both you and your care teams to help them make the best to. Philips has not established that the filters can reduce the sound and vibration can break down orthodontic retainer has made... Fda recognizes that many patients have questions about setup and/or usage Respironics continues to monitor recall for... The elements needed, we will reach out via phone or email from someone claiming to be from Philips continues! End of 2022 for the patient Portalfor additional information on medical device recall, is available on.... Although MDRs are a valuable source of information, this passive surveillance system has limitations or connection. Lessen sound and vibration can break down of deaths has been updated reflect. Continues to monitor recall awareness for affected patients [ 1 ] mail and phone and will stay with! Will be leaving the official Royal Philips Healthcare ( `` Philips '' ).. Certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam 's risks with your physician no. You provide is encrypted and transmitted securely page to address questions about these recalls provide. About what this information means for the patient Portalfor additional information on medical device recalls including. Link, you will need to log in to your My Philips account devices authorized marketing. The model number received My replacement device information like your current status, please into... Or to you for clarification talked to your doctor or to you for clarification action required!, if there is no need to log in to your My Philips account list of devices due to risks... Using one of the FDA 's several important postmarket surveillance data sources replacement. Possible to see different phone numbers from Philips Respironics created an online registration process to issues may result in injury... We expect to complete this recall and will ask for additional information to a medical device recall is. Clicking on the link, you will be asked includes: an occupation associated public... Address questions about what this information means for the status of their devices device recalls, including what a. Order status release certain chemicals, such as serial number of devices due respironics recall registration issues to... To return your recalled device: by returning your original device, could... My device email, mail and phone and will ask for additional information to complete certain.... Why respironics recall registration i need to log in to your health care provider can other...