The .gov means its official.Federal government websites often end in .gov or .mil. 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. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Before sharing sensitive information, make sure you're on a federal government site. The full report is available here. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Keep your registration confirmation number. endstream endobj startxref 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Koninklijke Philips N.V., 2004 - 2023. 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. 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? Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The site is secure. Use another similar device that is not a part of this recall. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. 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. You are about to visit the Philips USA website. 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. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. By returning your original device, you can help other patients. 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. Images may vary. To register by phone or for help with registration, call Philips at 877-907-7508. For further information, and to read the voluntary recall notification, visit philips.com/src-update. The returned affected device will be repaired for another patient that is waiting within the replacement process. What information do I need to provide to register a product? Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. If you are in crisis or having thoughts of suicide, You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. Secure .gov websites use HTTPS If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. If it has all the elements needed, we will enter an order for your replacement. 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. 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. No. Please switch auto forms mode to off. Please note: only certain devices made by Philips are subject to this recall. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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. Philips Respironics Sleep and Respiratory Care devices, 2. 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. Attention A T users. A locked padlock On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Learn more at www.vcf.gov . 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. The site is secure. Koninklijke Philips N.V., 2004 - 2023. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Didn't include your email during registration? Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. For more information of the potential health risks identified, see the FDA Safety Communication. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. 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. 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. Foam: Do not try to remove the foam from your device. Your replacement will come with a box to return your current device to Philips Respironics. visit VeteransCrisisLine.net for more resources. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. 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. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. 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 patients using life-sustaining ventilation, continue prescribed therapy. Before sharing sensitive information, make sure you're on a federal government site. For Spanish translation, press 2; Para espaol, oprima 2. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 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. Find out more about device replacement prioritization and our shipment of replacement devices. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 2. You can log in or create one here. 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. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. classified by the FDA as a Class I recall. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. 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. Please visit the Patient Portalfor additional information on your status. Consult with your physician as soon as possible to determineappropriate next steps. 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. 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 . I received a call or email from someone claiming to be from Philips Respironics. %%EOF Philips Respironics created an online registration process to allow patients to look up their device serial number . To enter and activate the submenu links, hit the down arrow. Philips Respironics continues to monitor recall awareness for affected patients [1]. Devices need to be registered with Philips Respironics to receive a replacement device. Why do I need to upload a proof of purchase? Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Looking for U.S. government information and services? These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . 1. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Call us at +1-877-907-7508 to add your email. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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). Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 2. 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. 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. Do not use ozone or ultraviolet (UV) light cleaners. Philips has pre-paid all shipping charges. Are there any other active field service notifcations or recalls of Philips Respironcs products? Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers In the US, the recall notification has been classified by the FDA as a Class I recall. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Overview. 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. 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. 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 . Trying to or successfully removing the foam may damage the device or change how the device works. Communications will typically include items such as serial number, confirmation number or order number. You can still register your device on DreamMapper to view your therapy data. 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. Medical guidance regarding this recall. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. You can also visit philips.com/src-update for information and answers to frequently asked questions. Koninklijke Philips N.V., 2004 - 2023. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 272 0 obj <> endobj For further information about your current status, please log into the portal or call 877-907-7508. 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. 1. 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. Membership. The more we know about these devices the more research we can do.". The FDA recognizes that many patients have questions about what this information means for the status of their devices. Only clean your device according to the manufacturers recommendations. Call us at +1-877-907-7508 to add your email. 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. For further information about your current status, please log into the portal or call 877-907-7508. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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