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 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. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. You can access the Philips RS North America webpage by clicking here. How it works. All patients who register their details will be provided with regular updates. We are in touch with relevant customers and patients. 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. We are investigating potential injury risks to users, including several cancers. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. However, this new recall does apply to some of the devices recalled in June 2021. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. All rights reserved. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. What is the advice for patients and customers? A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 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. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. 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. 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. Please note, the correction for Trilogy 100 is currently on hold. Patient safety is our top priority, and we are committed to supporting our . Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Koninklijke Philips N.V., 2004 - 2023. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. If you have a secondary back up device, switch over to that device. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Philips may work with new patients to provide potential alternate devices. 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. 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. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Have regulatory authorities classified the severity of the recall? For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. This could affect the prescribed therapy. . Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Click the link below to begin our registration process. 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. 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. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. 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 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. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. Selected products You can find the list of products that are not affected as part of the corrective actionhere. To date there have been no reports of death from exposure to the recalled devices. We thank you for your patience as we work to restore your trust. 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 refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. . 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. Follow those instructions. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Philips Quality Management System has been updated to reflect these new requirements. 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. All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Affected devices may be repaired under warranty. Plaintiffsfiled a Second Amended Complaint in November 2022. kidneys and liver) and toxic carcinogenic affects. The return shipment for your old device is pre-paid so there is no charge to you. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Go to www.philips.com/src-update and click on "Begin registration process" (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process") Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas) 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Membership & Community. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. We thank you for your patience as we work to restore your trust. 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. 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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. 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. Only machines with serial numbers identified in the companys communications are affected by this recall. 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. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. Please note that some people will also receive a copy of the Notice by email or post. 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. 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. 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. 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. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? 3. 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. 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. Always ensure you are being taken care of, i.e. 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. Consult with your physician as soon as possible to determine appropriate next steps. 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. If you have a secondary back up device, switch over to that device. The FDA has identified this as a Class I recall, the most serious type of recall. 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. This information has not been separately verified by Philips Electronics Australia Ltd. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Philips CPAPs cannot be replaced during ship hold. The list of, If their device is affected, they should start the. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. Please note, the correction for Trilogy 100 is currently on hold. Call us at +1-877-907-7508 to add your email. Discuss the best treatment course with the patient. You are about to visit the Philips USA website. Register your product and enjoy the benefits. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. The new material will also replace the current sound abatement foam in future products. 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 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. 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. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: For patients using life-sustaining mechanical ventilator devices: The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. The following updates in relation to device testing have been released by Philips RS North America on this webpage: Please note that the Philips RS North America website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia. 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? Register your device on the Philips recall website or call 1-877-907-7508. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. We thank you for your patience as we work to restore your trust. We thank you for your patience as we work to restore your trust. [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. 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 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. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. 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. 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. The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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