For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Consult with your physician as soon as possible to determineappropriate next steps. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. b. For patients using life-sustaining ventilation, continue prescribed therapy. Questions regarding registration, updating contact information (including address), or to cancel a registration. For patients using life-sustaining ventilation, continue prescribed therapy. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 3. To access the menus on this page please perform the following steps. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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. 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's 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. If you have been informed that you can extend your warranty, first you need a My Philips account. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. 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. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. 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. You can log in or create one. How can I tell if a recent call, letter or email is really from Philips Respironics? 2. Follow the recommendations above for the recalled devices used in health care settings. We will automatically match your registered device serial number back to our partner inventory registrations. The FDA has reached this determination based on an overall benefit-risk assessment. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. The foam cannot be removed without damaging the device. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Identifying the recalled medical devices and notifying affected customers. 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. 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. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 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. 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. There were no reports of patient injury or death among those 30 MDRs. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Keep your registration confirmation number. Dont have one? 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. 1. 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. Please note: only certain devices made by Philips are subject to this recall. Didn't include your email during registration? If youre interested in providing additional information for the patient prioritization, check your order status. 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 . Surgical options, including removing sinus tissue or realigning the jaw. 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. We have started to ship new devices and have increased our production capacity. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Foam: Do not try to remove the foam from your device. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. 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. Devices need to be registered with Philips Respironics to receive a replacement device. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. The full report is available here. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. 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. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. No. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Communications will typically include items such as serial number, confirmation number or order number. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Call us at +1-877-907-7508 to add your email. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Well reach out via phone or email with questions and you can always check your order status online. 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. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, 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). Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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 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. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. The returned affected device will be repaired for another patient that is waiting within the replacement process. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Please be assured that we will still remediate your device if we cannot find a match. 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. 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. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. 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. 22 Questions Consult with your physician as soon as possible to determineappropriate next steps. 1. How can I register my product for an extended warranty? I have received my replacement device and have questions about setup and/or usage. Please call our registration line or visit our registration website. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If you use one of these recalled devices, follow the recommendations listed below. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. The .gov means its official.Federal government websites often end in .gov or .mil. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. I would like to learn more about my replacement device. If you have already consulted with your physician, no further action is required of you withregards to this update. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. See the FDA Safety Communication for more 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. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. 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. 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 will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Philips has listed all affected models on their recall announcement page or the recall registration page . 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. 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