Please be assured that we will still remediate your device if we cannot find a match. 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. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + CHEST MEMBERSHIP About Membership . 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. More information is available at http://www.philips.com/src-update. My issue is not addressed here. Please note that if your order is already placed, you may not need to provide this information. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). In the US, the recall notification has been. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. We recommend you upload your proof of purchase, so you always have it in case you need it. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can create one here. 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. For patients using life-sustaining ventilation, continue prescribed therapy. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. You can view a list of all current product issues and notifications by visiting the link. You can log in or create one. 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. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. You may have to contact your care provider to program the device to your prescribed settings. You must register your recalled device to get a new replacement device. Images may vary. Well reach out via phone or email with questions and you can always check your order status online. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips has listed all affected models on their recall announcement page or the recall registration page . Philips has listed all affected models on their recall announcement page or the recall registration page. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Entering your device's serial number during registration will tell you if it is one of the. organization in the United States. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. 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. Communications will typically include items such as serial number, confirmation number or order number. To register your product, youll need to log in to your My Philips account. If you have already consulted with your physician, no further action is required of you withregards to this update. Please note: only certain devices made by Philips are subject to this recall. 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. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. 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 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Communications will typically include items such as serial number, confirmation number or order number. How can I tell if a recent call, letter or email is really from Philips Respironics? Attention A T users. 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). 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. For further information about your current status, please log in to the. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. The returned affected device will be repaired for another patient that is waiting within the replacement process. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. There were no reports of patient injury or death among those 30 MDRs. You are about to visit the Philips USA website. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. If you use one of these recalled devices, follow the recommendations listed below. 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Lock hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Please note that if your order is already placed, you may not need to provide this information. 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). Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Apologize for any inconvenience. Before sharing sensitive information, make sure you're on a federal government site. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Looking for U.S. government information and services? You can also upload your proof of purchase should you need it for any future service or repairs needs. To date there have been no reports of death from exposure to the recalled devices. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Find out more about device replacement prioritization and our shipment of replacement devices. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Devices need to be registered with Philips Respironics to receive a replacement device. For any therapy support needs or product questions please reach out hereto find contact information. 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 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. 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. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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. Create account Create an account Already have an account? Eight of those reports were from the U.S. Trying to or successfully removing the foam may damage the device or change how the device works. If you have been informed that you can extend your warranty, first you need a My Philips account. have hearing loss. Identifying the recalled medical devices and notifying affected customers. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. 0 Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. You are about to visit a Philips global content page. News and Updates> Important update to Philips US recall notification. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. classified by the FDA as a Class I recall. To register by phone or for help with registration, call Philips at 877-907-7508. 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. 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). Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. b. 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. 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Membership & Community. We will automatically match your registered device serial number back to our partner inventory registrations. %%EOF You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Dont have one? How can I register my product for an extended warranty? 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. Please call our registration line or visit our registration website. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. kidneys and liver) and carcinogenic effects. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. There are currently no items in your shopping cart. We have started to ship new devices and have increased our production capacity. 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. 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. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. 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. In this video, we will be going into detail about the process to register your device on the Philips website. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The full report is available here. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. Follow the recommendations above for the recalled devices used in health care settings. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Consult with your physician as soon as possible to determineappropriate next steps. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. An official website of the United States government. 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. All rights reserved. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 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: . The site is secure. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. The devices are used to help breathing. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 303 0 obj <>stream You can also visit philips.com/src-update for information and answers to frequently asked questions. 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). 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. 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. 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 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. Three types of devices have been recalled: 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 Trilogy 100 and Trilogy 200 ventilators. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers a. Philips CPAP Recall Information. 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