However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. 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. . The list of, If their device is affected, they should start the. This recall notification / field safety notice has not yet been classified by regulatory agencies. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. The device types are: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) 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. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Are you still taking new orders for affected products? Only machines with serial numbers identified in the companys communications are affected by this recall. 1800-28-63-020. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. 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. Philips Sleep and respiratory care. Doing this could affect the prescribed therapy. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) DreamStation Go With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. 4. If you have not done so already, please click here to begin the device registration process. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. If your physician determines that you must continue using this device. 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. Always ensure you are being taken care of, i.e. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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). There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. The recall is a high-profile problem that has affected millions of patients in the U.S. and other countries for almost two years, and those . 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. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. High heat and high humidity environments may also contribute to foam degradation in certain regions. How long will it take to address all affected devices? For more information about your replacement device including video instructions click 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 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. We are in touch with relevant customers and patients. Select your country. The letter offered the following recommendations. The potential risks associated with this recall include: If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death. It includes further information such as what steps are available to Group Members in the class action. 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. Once you receive your replacement device, you will need to return your old device. 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. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. We thank you for your patience as we work to restore your trust. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. How are you removing the old foam safely? For any other matters not directly related to Investor Relations, please visit our company contactspage. Additionally, the device Instructions for Use provide product identification information to assist with this activity. 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; Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. 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. Medical Device recall notification (U.S. only) / field safety notice (International Markets). 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. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. What is the cause of this issue? [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models 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. Please note that the information available at these links has not been separately verified by Philips Australia. 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. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. At the bottom of the page, select "I am a Patient/Device User/Caregiver". This could affect the prescribed therapy. All rights reserved. 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. Create account Create an account UPDATENovember 6, 2022: After further review of medical device reports, the FDA has revised the list of potential risks associated with this recall in the section, Reason for Recall. Philips has been in full compliance with relevant standards upon product commercialization. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. What happens after I register my device, and what do I do with my old device? How did this happen, and what is Philips doing to ensure it will not happen again? With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Have regulatory authorities classified the severity of the recall? The contacts included Durable Medical Equipment (DME) suppliers. If your physician determines that you must continue using this device, use an inline bacterial filter. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. What devices have you already begun to repair/replace? For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Is this a recall? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. We thank you for your patience as we work to restore your trust. Philips CPAPs cannot be replaced during ship hold. However, this new recall does apply to some of the devices recalled . 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. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. 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. For Spanish translation, press 2; Para espaol, oprima 2. . Updating everyone on what they need to know and do, and to participate in the corrective action. [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. 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. 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. 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. Koninklijke Philips N.V., 2004 - 2023. 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. 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. Is there any possibility others are affected? You are about to visit a Philips global content page. As a first step, if your device is affected, please start theregistration process here. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. At this time, Philips is unable to set up new patients on affected devices. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Particles or other visible issues? Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Call us at +1-877-907-7508 to add your email. 1. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Was it a design, manufacture, supplier or other problem? 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 Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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). Register your device at the Phillips Respironics website (link below). Selected products Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). Should affected devices be removed from service? 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Philips has been in full compliance with relevant standards upon product commercialization. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. 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. See all support information Theremediation of this field safety notice is underway and has started for the following devices: Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. 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