The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Membership. Koninklijke Philips N.V., 2004 - 2023. Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. We thank you for your patience as we work to restore your trust. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). *Note*: You can also call 877-907-7508 to register your device. Membership & Community. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. 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. Philips CPAPs cannot be replaced during ship hold. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. [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. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). https://doi.org/10.1183/13993003.00551-2022, Continued patient outreach through mailing, call center, websites and direct contact with interest groups, Met the requirements in FDA's 518(a) order and continue to report progress, 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, 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, Lowprevalence of significant visible foam degradation, Evenwhen significant visible particulates are formed, likely to accumulate insidethe device, 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, 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. The relevant subsidiaries are cooperating with the agency. At this time, Philips is unable to set up new patients on affected devices. Philips Sleep and respiratory care. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. This could affect the prescribed therapy. The new material will also replace the current sound abatement foam in future products. Please read the Notice carefully. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. 2. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. Have regulatory authorities classified the severity of the recall? Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model. We know how important it is to feel confident that your therapy device is safe to use. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Are you still taking new orders for affected products? Formal discovery has started, and it isexpected to continue throughout 2023 and beyond, SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. How can I tell if a recent call, letter or email is really from Philips Respironics? Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. Affected devices may be repaired under warranty. Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider. Click the link below to begin our registration process. Is there any possibility others are affected? This information has not been separately verified by Philips Electronics Australia Ltd. Will existing patient devices that fail be replaced? At the bottom of the page, select "I am a Patient/Device User/Caregiver". 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). When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. 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. We thank you for your patience as we work to restore your trust. 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. 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. 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. The products were designed according to, and in compliance with, appropriate standards upon release. We thank you for your patience as we work to restore your trust. Are spare parts currently part of the ship hold? You are about to visit a Philips global content page. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Leandro Mazzoni Head of Investor Relations, Rashiq Muhaimen Investor Relations Manager ESG related topics, Investor Relations Manager ESG related topics, Monique van der Heiden Corporate Access Manager. 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 potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. Patients who are concerned should check to see if their device is affected by the corrective action. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Doing this could affect the prescribed therapy. 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. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. 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. Don't have one? 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. 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. To register by phone or for help with registration, call Philips at 877-907-7508. 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. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. How are you removing the old foam safely? Philips Respironics initiated a voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices. It includes further information such as what steps are available to Group Members in the class action. However, this new recall does apply to some of the devices recalled . Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). This recall notification / field safety notice has not yet been classified by regulatory agencies. Can we help? That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. You can access the Philips RS North America webpage by clicking here. [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. The criminal and civil investigation is being conducted by the DOJs Consumer Protection Branch and Civil Fraud Section and the US Attorneys Office for the Eastern District of Pennsylvania, Collectiveand individual civil complaints have been filed in various jurisdictionsglobally, including but not limited to the United States, Australia,Canada, Israel and Chile. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. 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. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. After registration, we will notify you with additonal information as it becomes available. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. Additional Resources: Medical Device Recall. Overview. Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. For more information on the recall notification for customers, users and physicians, please click here. Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use. In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. Follow those instructions. 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. Plaintiffsfiled a Second Amended Complaint in November 2022. The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. The device types are: For patients who registered their DreamStation Go, Philips Australia commenced the replacement program for DreamStation Go devices in December 2022 and it will continue into Q1 2023. 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. Once you receive your replacement device, you will need to return your old device. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. If their device is affected, they should start theregistration process here. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). What is the advice for patients and customers? We thank you for your patience as we work to restore your trust. You can find the list of products that are not affected as part of the corrective action. You are about to visit the Philips USA website. Philips Quality Management System has been updated to reflect these new requirements. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. Please note, the correction for Trilogy 100 is currently on hold. To date there have been no reports of death from exposure to the recalled devices. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. You can register here. Why did Philips issue the global recall notification in June 2021? [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Do affected units exhibit features that customers / users should watch out for? 1800-28-63-020. 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. * Voluntary recall notification in the US/field safety notice for the rest of the world. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. Philips is notifying regulatory agencies in the regions and countries where affected products are available. For more information on the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand, as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this correction, do not try to remove the foam from your device. 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. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. How it works. Philips has been in full compliance with relevant standards upon product commercialization. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a claim if their unit is affected. 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