This potentially deadly combination . Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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? Have regulatory authorities classified the severity of the recall? Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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. This recall notification / field safety notice has not yet been classified by regulatory agencies. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . What is the advice for patients and customers? After registration, we will notify you with additonal information as it becomes available. 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 new material will also replace the current sound abatement foam in future products. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. On June 14th, 2021, Philips Respironics released a safety communication statement that they will be issuing a device recall for almost all of their machines sold from 2009 to the present day. 2. 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. 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. Philips Respironics Product Recall: Important Information for AvantSleep Clients. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Philips CPAP Recall Information. 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). Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. Selected products What happens after I register my device, and what do I do with my old device? 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). Follow those instructions. How long will it take to address all affected devices? CHEST Issues Joint Statement in Response to Philips Device Recall . Select your country. At the bottom of the page, select "I am a Patient/Device User/Caregiver". 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. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. You are about to visit a Philips global content page. Is this a recall? 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. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. You are about to visit the Philips USA website. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. Can I trust the new foam? Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. 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? 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). Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Why did Philips issue the global recall notification in June 2021? 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. 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. Koninklijke Philips N.V., 2004 - 2023. For more information on the recall notification for customers, users and physicians, please click here. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. Register your device on the Philips recall website or call 1-877-907-7508. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Plaintiffsfiled a Second Amended Complaint in November 2022. Will existing patient devices that fail be replaced? Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). This could affect the prescribed therapy. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Koninklijke Philips N.V., 2004 - 2023. 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. Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio. 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 recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. If your physician determines that you must continue using this device. Philips CPAPs cannot be replaced during ship hold. 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. Consult your Instructions for Use for guidance on installation. Can Philips replace products under warranty or repair devices under warranty? For more information about your replacement device including video instructions click. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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; 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. Should affected devices be removed from service? 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. 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. The application for discontinuance will be heard by the Federal Court on 3 April 2023. This information has not been separately verified by Philips Electronics Australia Ltd. 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. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 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. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. If you do not have this letter, please call the number below. Replace these devices with an unaffected device. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models For more information click here. Click "Next". Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. All rights reserved. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and corrected devices is a silicone foam. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. 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. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. 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