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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Are affected devices continuing to be manufactured and/or shipped? Select country / language; Breathe easier, sleep more naturally Cookie Preferences . At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. We thank you for your patience as we work to restore your trust. 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. Selected products Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. 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. 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. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, was corrected or replaced through the June 2021 recall, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, report adverse reactions or quality problems, Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. Before sharing sensitive information, make sure you're on a federal government site. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 2. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. What is the safety hazard associated with this issue? Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The new material will also replace the current sound abatement foam in future products. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. All rights reserved. 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. 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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. The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. 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. This factor does not refer to heat and humidity generated by the device for patient use. Consult your Instructions for Use for guidance on installation. For further information please contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. December 2, 2021 (latest update) . Select your country. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). Philips has been in full compliance with relevant standards upon product commercialization. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). 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. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . 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 recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Patient safety is our top priority, and we are committed to supporting our . You are about to visit the Philips USA website. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). 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. Updating everyone on what they need to know and do, and to participate in the corrective action. 2. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). Is Philips certain that this issue is limited to the listed devices? Always ensure you are being taken care of, i.e. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. This recall notification / field safety notice has not yet been classified by regulatory agencies. For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit. High heat and high humidity environments may also contribute to foam degradation in certain regions. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . It includes further information such as what steps are available to Group Members in the class action. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. For Spanish translation, press 2; Para espaol, oprima 2. . Affected devices may be repaired under warranty. Medical Device recall notification (U.S. only) / field safety notice (International Markets). 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. The return shipment for your old device is pre-paid so there is no charge to you. We have established a claims processing and support center to assist you. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Replace these devices with an unaffected device. 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. Only machines with serial numbers identified in the companys communications are affected by this recall. Use of these devices may cause serious injuries or death. 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. Can Philips replace products under warranty or repair devices under warranty? Plaintiffsfiled a Second Amended Complaint in November 2022. What is the cause of this issue? Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. 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. We know how important it is to feel confident that your therapy device is safe to use. 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. At this time, affected devices are on manufacturing and ship hold. 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. 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; 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. 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. The relevant subsidiaries are cooperating with the agency. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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. [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. 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. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected by the corrective action. If you have not done so already, please click here to begin the device registration process. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. We thank you for your patience as we work to restore your trust. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. Was it a design, manufacture, supplier or other problem? Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration. 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). 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). All patients who register their details will be provided with regular updates. The relevant subsidiaries are cooperating with the agency. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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