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. See all support information I would like to learn more about my replacement device. 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. Although MDRs are a valuable source of information, this passive surveillance system has limitations. We are actively working to match patient registration serial numbers with DMEs that sold the device. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Philips CPAP Recall Information.
*The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Is there a question we can answer for you? SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Apologize for any inconvenience. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Official websites use .gov
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. Foam: Do not try to remove the foam from your device. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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. For further information about your current status, please log into the portal or call 877-907-7508. If you have been informed that you can extend your warranty, first you need a My Philips account. hbbd``b`
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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. Philips Respironics Sleep and Respiratory Care devices, 2. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Lifestyle Measures to Manage Sleep Apnea fact sheet. Attention A T users. Koninklijke Philips N.V., 2004 - 2023. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Register your product and start enjoying benefits right away. 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. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. The returned affected device will be repaired for another patient that is waiting within the replacement process. Not yet registered? You are about to visit a Philips global content page. 0
How can I tell if a recent call, letter or email is really from Philips Respironics? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. classified by the FDA as a Class I recall. 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. More information is available at http://www.philips.com/src-update. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. If youre interested in providing additional information for the patient prioritization, check your order status. 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. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. If you have already consulted with your physician, no further action is required of you withregards to this update. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. 22 Questions Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . I have general DreamMapper questions or DreamMapper connection issues. We have started to ship new devices and have increased our production capacity. The .gov means its official.Federal government websites often end in .gov or .mil. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Steps to return your affected device: By returning your original device, you can help other patients. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. 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.
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. ) or https:// means youve safely connected to
For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Creating a plan to repair or replace recalled devices. visit VeteransCrisisLine.net for more resources. endstream
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Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Please switch auto forms mode to off. We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. Philips 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). CHEST Issues Joint Statement in Response to Philips Device Recall . Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. If you are in crisis or having thoughts of suicide,
The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. We will keep the public informed as more information becomes available. In this video, we will be going into detail about the process to register your device on the Philips website. * This is a recall notification for the US only, and a field safety notice for the rest of the world. You are about to visit a Philips global content page. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Cleaning, setup and return instructions can be found here. Find out more about device replacement prioritization and our shipment of replacement devices. The devices are used to help breathing. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. My issue is not addressed here. 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. In the US, the recall notification has been classified by the FDA as a Class I recall. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. What information do I need to provide to register a product? The foam cannot be removed without damaging the device. Register your product and start enjoying benefits right away. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Determining the number of devices in use and in distribution. 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. You are about to visit a Philips global content page. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. That will allow them place an order for your supplies. Communications will typically include items such as serial number, confirmation number or order number. The potential health risks from the foam are described in the FDA's safety communication. 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. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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. Then you can register your product. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. For patients using life-sustaining ventilation, continue prescribed therapy. I am experiencing technical issues with the Patient Portal. Call us at +1-877-907-7508 to add your email. 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