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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 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. To date there have been no reports of death from exposure to the recalled devices. 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. What is the safety hazard associated with this issue? This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. ~90%production and 80% shipment of recall units, Encouraging test results for DS1platform (within safety norms), 483remediation and clarity on proposed Consent Decree, Driving patient engagement and registrations with dedicated registration system and infrastructure Continued patient outreach through mailing, call center, websites and direct contact with interest groups Comprehensive DME outreach Met the requirements in FDA's 518(a) order and continue to report progress Ongoing engagement with regulators to optimize the recall efforts Sharing progress on testing program to ensure patients and physicians fully informed, The task at hand 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, Progress to date 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, VOCtesting Emissions within ISO limits(devices not exposed to ozone) Visualinspection and assessment of the foam in used devices Lowprevalence of significant visible foam degradation Evenwhen significant visible particulates are formed, likely to accumulate insidethe device ParticulateMatter testing Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits Bioassayevaluation, chemical characterization and toxicological risk assessment Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Emissions within ISO limits(devices not exposed to ozone), Visualinspection and assessment of the foam in used devices, Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits, Bioassayevaluation, chemical characterization and toxicological risk assessment, Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, 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 here for more details Two of the studies[1] [2]showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices 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. All rights reserved. You are about to visit a Philips global content page. The return shipment for your old device is pre-paid so there is no charge to you. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Please note that some people will also receive a copy of the Notice by email or post. The company has developed a comprehensive plan for this correction, and has already begun this process. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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 Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. 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. Do affected units exhibit features that customers / users should watch out for? The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. You are about to visit the Philips USA website. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. 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. 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. Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. 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. Register your device on the Philips recall website or call 1-877-907-7508. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? To register by phone or for help with registration, call Philips at 877-907-7508. How it works. Follow the steps for registering your device. We have established a claims processing and support center to assist you. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Before sharing sensitive information, make sure you're on a federal government site. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. For more information click here. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. The list ofaffected devices can be found here. Philips Sleep and respiratory care. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. Click the link below to begin our registration process. 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). At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues. The .gov means its official.Federal government websites often end in .gov or .mil. 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. As a first step, if your device is affected, please start the. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. The application for discontinuance will be heard by the Federal Court on 3 April 2023. The return shipment for your old device is pre-paid so there is no charge to you. 3. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). Can Philips replace products under warranty or repair devices under warranty? In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Philips is notifying regulatory agencies in the regions and countries where affected products are available. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. 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 Quality Management System has been updated to reflect these new requirements. All rights reserved. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. 4. 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. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . 2. 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 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. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? For any other matters not directly related to Investor Relations, please visit our company contactspage. Philips may work with new patients to provide potential alternate devices. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. Koninklijke Philips N.V., 2004 - 2023. Philips CPAPs cannot be replaced during ship hold. Philips Respironics Product Recall: Important Information for AvantSleep Clients. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. 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. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. 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. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . December 2, 2021 (latest update) . 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. 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. Consult with your physician to determine the benefits of continuing therapy and potential risks. Koninklijke Philips N.V., 2004 - 2023. How are you removing the old foam safely? 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. This potentially deadly combination . 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. 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. Contact your clinical care team to determine if a loan device is required. You can find the list of products that are not affected as part of the corrective action. Have regulatory authorities classified the severity of the recall? Testing is ongoing and you can obtain further information about the. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. 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. 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. 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. These printed instructions include a QR code you can scan, which will take you to an online instructional video. If you have not done so already, please click here to begin the device registration process. Are affected devices safe for use? 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. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). 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. How did this happen, and what is Philips doing to ensure it will not happen again? This could affect the prescribed therapy. 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: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. 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. 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. Recall website or call 1-877-907-7508 be assured that our teams are working on a government! ( U.S. only ) / field safety Notice ( International Markets ) this! 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