Please note that the Patient Portal is for U.S. patients only. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. 3014, #2 Exhibit A - Notice of Potential Tag-Along Action, #3 . 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. Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips organic business and the completion of acquisitions and divestments. If you registered a DreamStation or SystemOne device and have not yet received your replacement device, it may be because Philips Respironics is waiting for important information or consent from you. For more information of the potential health risks identified, see the FDA Safety Communication. Results have a margin of error of +/- 2% at a 95% confidence level for the overall population. We understand that any change to your therapy device can feel significant. Philips Respironics continues to monitor recall awareness for affected patients [1]. We will continue to provide regular updates to you through monthly emails. As a first step, if your device is affected, please start the registration process here. Medical Device Recall Notification - CareFirst The prompts you may see include sharing prescription information or selecting a specific remediation option based on your affected device type. Before sharing sensitive information, make sure you're on a federal government site. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Important information about patient prioritization | Philips If the Patient Portal shows that your order has been placed, you cannot update your information. Amsterdam, the Netherlands - Following the company update on April 26, 2021, Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential. We know how important it is to feel confident that your therapy device is safe to use. We understand the profound impact this recall has had on you, and that for those who are waiting for a repaired or replaced device, this progress cant come quickly enough. All rights reserved. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Koninklijke Philips N.V., 2004 - 2023. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series), Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US), Also known as BiPAP V30 Auto Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). In the US, Philips launched the patient portal and ability to update existing patient registration information at the end of February 2022. We understand that any change to your therapy device can feel significant. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). In addition, you will have the opportunity to update your demographic and health information to be used to prioritize device remediation including your age, related health conditions, OSA severity, pregnancy, occupation, if youve had a history of car accidents related to falling asleep while driving, if youve identified foam particulates in your affected device, and if youve used ozone for device cleaning purposes. Have a non-critical service request? News about Philips can be found at, https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220311-philips-respironics-provides-update-for-the-us-on-ongoing-cpap-bipap-and-mechanical-ventilator-field-action.html. Creating a plan to repair or replace recalled devices. Do not use ozone or ultraviolet (UV) light cleaners. As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. This is because your status may have been updated or there may be important reminders for information needed to complete your order. For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit. The prompts you may see include sharing prescription information or selecting a specific remediation option based on your affected device type. The US Food and Drug Administration (FDA) updated its Philips Respironics recall safety communication to provide updated information about medical device reports that the agency received from Jan 1 to March 31.. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . You will need to exchange the device you have when a replacement becomes available. What information do I need to have ready to update my registration information in the patient portal? The company intends to complete the repair and replacement programs within approximately 12 months. Philips Sleep and respiratory care. Philips is working cooperatively with the FDA and other competent authorities to update them on new test data as they become available. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Philips provides update on voluntary recall notification - News | Philips The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). 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 FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. We wanted to remind you about our Patient Portal, why you should continue to visit it and how you can access it. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Data collected as inputs include patient age, related health conditions, OSA severity, pregnancy, occupation associated with public safety, history of car accidents related to falling asleep while driving, positive identification of foam particulates, and usage of ozone for device cleaning purposes. Philips Respironics, Inc., is recalling its Continuous and Non-Continuous Ventilators due to the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to . The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. 14841488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz. Repairing and replacing the recalled devices. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. 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. Please be assured that we are doing all we can to resolve the issue as quickly as possible. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Amsterdam, the Netherlands Royal Philips (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, today provided an update on the remediation status in the US of the ongoing recall of certain sleep and respiratory care products in connection with identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. The FDA recognizes that many patients have questions about what this information means for the status of their devices. The .gov means its official.Federal government websites often end in .gov or .mil. Dutch medical devices maker Philips INPHI said on Tuesday that independent tests have shown that the use of its respiratory devices involved in a major global recall did not cause health risks for patients.. Philips said "rigorous testing" by external parties on the range of DreamStation machines used to treat sleep apnoea showed positive results, confirming preliminary results released last year. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. More information can be found on the Patient Portal and if you experience any issues on the Patient Portal call 877-907-7508 Updating your device registration with additional demographic and health information does not guarantee that you will receive your device more quickly. More information can be found on the Patient Portal and if you experience any issues on the Patient Portal call 877-907-7508. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. The Patient Portal: Why you should use it and what to expect - Philips 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. If you have not done so already, please click here to begin the device registration process. Called Zix and they were able to trace their logs to confirm the email and the portal link in the email are legit. The Philips Respironics recall was announced in June 2021 and this CPAP recall affected millions of units. We are partnering with clinicians and business customers throughout this process to ensure were doing all we can to help you and your healthcare needs. Key Resources . The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows: For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include: Stopping use of an affected device Using another similar device that is not part of the recall Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. Latest CPAP Recall Updates: FDA Green Lights Repair and Replacement Program for Philips' DreamStation Recall September 2, 2021 Read the Latest FAQs About the Recall CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. Deaths reported with Philips ventilators, sleep apnea machines still Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. 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). The analysis and conclusion were based on data from a large multicenter cohort study involving 6,900 OSA patients on PAP devices between 2012 and 2020, including 1,200 Philips Respironics PAP users. Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution. U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit www.philips.com/ds2-replacement for more information. Koninklijke Philips N.V., 2004 - 2023. It was a Philips DreamStation recall, among many o. You are about to visit a Philips global content page, Philips Investor Relations Tel:+31 20 59 77055. For US patients whose remediation is directly managed by Philips Respironics, data collected throughout the patient registration process is used to help to prioritize remediation of those patients potentially at higher risk. Login with your account. Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. As a result, testing and assessments have been carried out. Philips Respironics Recalls Certain Continuous and Non-Continuous Philips Global Press Office Tel: +31 6 10888824. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. Doing this could affect the prescribed therapy and may void the warranty. Reason for Recall. Further testing and analysis is ongoing. 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. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. It is important to note that if there is action for you to take in the Patient Portal, we may be unable to move forward with your replacement device until you log in and take the appropriate action requested of you. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Philips DreamStation CPAP Recall Updates (2023) Comprehensive particulate testing and analyses for the first-generation DreamStation devices are expected to be completed in the second quarter of 2022. Koninklijke Philips N.V., 2004 - 2023. 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. The FDA has received more than 98,000 complaints about the original Philips recall since April 2021. 1-800-345-6443 then press #, or email them at pcms.support@philips.com. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. This could affect the prescribed therapy and may void the warranty. If you have already added prioritization information during your original registration or through the Patient Portal, you will not see the button to update your information. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly.