Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Plaintiffsfiled a Second Amended Complaint in November 2022. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. 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). 1800-28-63-020. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Testing is ongoing and you can obtain further information about the testing and matters relating to the recall from the device manufacturer, Philips RS North America LLC. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. The contacts included Durable Medical Equipment (DME) suppliers. The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Testing is ongoing and you can obtain further information about the testing and matters relating to the recall from the device manufacturer, Philips RS North America LLC. 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). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Only machines with serial numbers identified in the companys communications are affected by this recall. Before sharing sensitive information, make sure you're on a federal government site. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Contact your clinical care team to determine if a loan device is required. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Koninklijke Philips N.V., 2004 - 2023. Click the link below to begin our registration process. 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. 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. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. 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 (International markets) / voluntary recall notification (U.S. only). Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Selected products We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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 . All oxygen concentrators, respiratory drug delivery products, airway clearance products. For Spanish translation, press 2; Para espaol, oprima 2. . On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. The application for discontinuance will be heard by the Federal Court on 3 April 2023. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Philips Australia will work with your clinical care team to arrange a loan device, where required. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. We have established a claims processing and support center to assist you. CHEST Issues Joint Statement in Response to Philips Device Recall . Distribution Dates: August 6, 2020, to September 1, 2021, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. This could affect the prescribed therapy. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. Additional Resources: Medical Device Recall. Are customers entitled to warranty replacement, repair, service or other mitigations? All rights reserved. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. This Alert was related only to Trilogy 100 ventilators that were repaired. 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? The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP, System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series). Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Click "Next". The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. What is the safety hazard associated with this issue? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options. Doing this could affect the prescribed therapy. - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. As part of the notification process, customers and patients will be provided with more information on the next steps to implement the solution as it becomes available. It includes further information such as what steps are available to Group Members in the class action. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. The relevant subsidiaries are cooperating with the agency. Create account Create an account The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. For more information on the recall notification for customers, users and physicians, please click here. If your physician determines that you must continue using this device, use an inline bacterial filter. The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. On June 14, Philips issued a recall for many of its CPAP, BiPAP and ventilator machines because of concerns that users may inhale small particles of the foam used to dampen sound while the machines are in use. Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. If separation of the foam from the plastic backing was to occur, to the extent that therapy is impacted, your device will issue a High Priority alarm, either Low Inspiratory Pressure or Circuit Disconnect. You can register here. All rights reserved. Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. For more information about your replacement device including video instructions click here. Philips will be moving to dismiss theSecond Amended Complaint Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters. You are about to visit a Philips global content page. Philips will be moving to dismiss theSecond Amended Complaint, Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters, Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues, These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers, The FDA acknowledges that the submission of an. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. Process Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers The FDA acknowledges that the submission of anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. If you have a secondary back up device, switch over to that device. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Testing is ongoing and you can obtain further information about the. If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen; 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 Where do I direct questions about my replacement device? The plastic may also cause the machine to fail and stop working suddenly during use. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Royal Philips (NYSE: PHG) is promising a turnaround from its bottom-line woes, which began with one of the largest medical devices recalls in recent history. For more information click here. See all support information Overview. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. Particles or other visible issues? Please read the Notice carefully. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. . As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Please note that some people will also receive a copy of the Notice by email or post. ~90%production and 80% shipment of recall units, Encouraging test results for DS1platform (within safety norms), 483remediation and clarity on proposed Consent Decree, Driving patient engagement and registrations with dedicated registration system and infrastructure Continued patient outreach through mailing, call center, websites and direct contact with interest groups Comprehensive DME outreach Met the requirements in FDA's 518(a) order and continue to report progress Ongoing engagement with regulators to optimize the recall efforts Sharing progress on testing program to ensure patients and physicians fully informed, The task at hand Around 5.5M devices expected to berepaired or replaced Equivalent to over 5x previous annualproduction volume >1 thousand new product configurationsreleased globally Partnering with DMEs for patientdelivery, Progress to date Quadrupledproduction capacity compared to pre-recall >1,000people cross functional team engaged Dependencyon supply of materials and global logistics capacity ~90% production and 80% shipment of recall units in 2022, VOCtesting Emissions within ISO limits(devices not exposed to ozone) Visualinspection and assessment of the foam in used devices Lowprevalence of significant visible foam degradation Evenwhen significant visible particulates are formed, likely to accumulate insidethe device ParticulateMatter testing Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits Bioassayevaluation, chemical characterization and toxicological risk assessment Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Emissions within ISO limits(devices not exposed to ozone), Visualinspection and assessment of the foam in used devices, Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits, Bioassayevaluation, chemical characterization and toxicological risk assessment, Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Finalizetoxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in DreamStation1 devices Expected in Q2 2023 Completetesting for SystemOne(~26% of registered devices) and DreamStationGo (~1%), which contain the exact same foam as the DreamStation1 devices Expected in Q2 2023 CompleteVOC and PM testing, as well as chemical evaluation and toxicologicalassessments for Trilogy 100/200 (~3%) and OmniLab(~2%), where a different PE-PUR foam is used Expected in Q3 2023 Ongoingengagement with FDA and other competent authorities, There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click here for more details Two of the studies[1] [2]showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. At this time, Philips is unable to set up new patients on affected devices. Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Register your product and enjoy the benefits. Philips is notifying regulatory agencies in the regions and countries where affected products are available. 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