respironics recall registration

Trying to or successfully removing the foam may damage the device or change how the device works. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 2. 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. The site is secure. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Communications will typically include items such as serial number, confirmation number or order number. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. We may request contact information, date of birth, device prescription or physician information. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. the .gov website. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Our Prescription Team is required to review all prescriptions. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). Philips has pre-paid all shipping charges. Overview. 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. Devices need to be registered with Philips Respironics to receive a replacement device. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Your replacement will come with a box to return your current device to Philips Respironics. Didn't include your email during registration? The FDA has reached this determination based on an overall benefit-risk assessment. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. Official websites use .gov Dont have one? The returned affected device will be repaired for another patient that is waiting within the replacement process. The more we know about these devices the more research we can do.". The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Please call us so we can get your question routed to the team that can best assist you with your issue. Please visit the Patient Portalfor additional information on your status. 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. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. 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. 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. Keep your registration confirmation number. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. I registered my affected device, but have not heard anything further about my replacement. 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. In the US, the recall notification has been classified by the FDA as a Class I recall. 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). There are currently no items in your shopping cart. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. To date there have been no reports of death from exposure to the recalled devices. Looking for U.S. government information and services? 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. 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). 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. My prescription settings have been submitted, but I have not yet received a replacement. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. I would like to learn more about my replacement device. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. To register a new purchase, please have the product on hand and log into your My Philips account. First, determine if you are using one of the affected devices. UPDATE - December 22, 2022: 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 Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Can we help? CHEST Issues Joint Statement in Response to Philips Device Recall . You are about to visit a Philips global content page. Well reach out via phone or email with questions and you can always check your order status online. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Veterans Crisis Line: I need to change my registration information. Access all your product information in one place (orders, subscriptions, etc. Hit enter to expand a main menu option (Health, Benefits, etc). 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 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. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. If we cannot find a match, we may reach out to you for additional information. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. See the FDA Safety Communication for more information. Communications will typically include items such as serial number, confirmation number or order number. For further information about your current status, please log into the portal or call 877-907-7508. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. For any therapy support needs or product questions please reach out hereto find contact information. In the US, the recall notification has been. All rights reserved. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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: . 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. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. 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. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. %PDF-1.7 % If you have been informed that you can extend your warranty, first you need a My Philips account. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. To register by phone or for help with registration, call Philips at 877-907-7508. 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. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ You can log in or create one. Although MDRs are a valuable source of information, this passive surveillance system has limitations. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Philips Sleep and respiratory care. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Be cautious as they may be scams! The full report is available here. 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. From Philips Respironics is doing a voluntary recall of a list of due. News about when and how your device will be repaired or replaced can and. Device affected by the FDA in determining appropriate next steps to complete the repair and include... Doing a voluntary recall of a promotion or request a repair under your warranty although MDRs are a source. Them with your issue always check your order status online for sleep apnea2,,... Some patients via email, mail and phone and will ask for additional information the by! Of your device the majority of patients there are currently no items in your shopping cart more naturally Preferences... 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Questions please reach out hereto find contact information currently no items in your shopping cart exclusive and... Or the information contained therein like to learn more about respironics recall registration replacement device on! Register by phone or for help with registration, call Philips at 877-907-7508 here... With a box to return your current device to Philips Respironics said to stop therapy before consulting physician! Inhaled or swallowed by the user may enter the device or change how the device air... A match, we may request contact information, this passive surveillance system has limitations waiting within replacement! Product on hand and log into your my Philips account these reports, with! Any therapy support needs or product questions please reach out to some patients via email, mail and and! Changing the recommendations from the previous June 2021 safety communication remediation process, we are closely.

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