The application for discontinuance will be heard by the Federal Court on 3 April 2023. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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 new material will also replace the current sound abatement foam in future products. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). 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. Membership. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). * Voluntary recall notification in the US/field safety notice for the rest of the world. We thank you for your patience as we work to restore your trust. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. Talk with health care providers to decide if your care and treatment should change as a result of this recall. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 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). Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. At the bottom of this website, click Patient/Device User . *Note*: You can also call 877-907-7508 to register your device. If you have not done so already, please click here to begin the device registration process. 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 list ofaffected devices can be found here. 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. 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. Always ensure you are being taken care of, i.e. 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. The affected products are identified in the tables below: A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), 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 will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. 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. 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. Please note, the correction for Trilogy 100 is currently on hold. 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. Register your device (s) on Philips' recall website . To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). 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. These printed instructions include a QR code you can scan, which will take you to an online instructional video. 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. Philips Australia will work with your clinical care team to arrange a loan device, where required. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Once you receive your replacement device, you will need to return your old device. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Philips CPAPs cannot be replaced during ship hold. The .gov means its official.Federal government websites often end in .gov or .mil. 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. For more information click here. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The new material will also replace the current sound abatement foam in future products. 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 complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 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+. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. CHEST Issues Joint Statement in Response to Philips Device Recall . Will existing patient devices that fail be replaced? 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. 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 may work with new patients to provide potential alternate devices. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Are affected devices being replaced and/or repaired? 3. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. 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. You can find the list of products that are not affected as part of the corrective action. 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 cause of 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. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. The complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall, In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending, In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. Follow the steps for registering your device. Contact your clinical care team to determine if a loan device is required. 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. The relevant subsidiaries are cooperating with the agency. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance 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. 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. What is meant by "high heat and humidity" being one of the causes of this issue? 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. 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. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Contact your clinical care team to determine if a loan device is required. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. 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. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. After registration, we will notify you with additonal information as it becomes available. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click, Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations, Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis, In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. 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 are a patient who has been affected by this correction, please do not try to remove the foam from your device. See all support information How it works. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Create account Create an account The return shipment for your old device is pre-paid so there is no charge to you. This Alert was related only to Trilogy 100 ventilators that were repaired. 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. Should affected devices be removed from service? As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Don't have one? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Always ensure you are being taken care of, i.e. For Spanish translation, press 2; Para espaol, oprima 2. . Philips has been in full compliance with relevant standards upon product commercialization. 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. We thank you for your patience as we work to restore your trust. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. 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. ~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. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. How long will it take to address all affected devices? 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. No further products are affected by this issue. Have regulatory authorities classified the severity of the recall? What happens after I register my device, and what do I do with my old device? You are about to visit a Philips global content page. It includes further information such as what steps are available to Group Members in the class action. 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 . 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. High heat and high humidity environments may also contribute to foam degradation in certain regions. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. If you have a secondary back up device, switch over to that device. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. The products were designed according to, and in compliance with, appropriate standards upon release. On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. We thank you for your patience as we work to restore your trust. 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. High heat and high humidity environments may also contribute to foam degradation in certain regions. Updating everyone on what they need to know and do, and to participate in the corrective action. Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. 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. The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. Are spare parts currently part of the ship hold? Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 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. To date there have been no reports of death from exposure to the recalled devices. 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. 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. 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. If you have a secondary back up device, switch over to that device.

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