For more information on the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand, as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this correction, do not try to remove the foam from your device. - 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. Can Philips replace products under warranty or repair devices under warranty? Philips will provide further information regarding warranty replacement procedures during this issue when it is available. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. What happens after I register my device, and what do I do with my old device? If you do not have this letter, please call the number below. *Note*: You can also call 877-907-7508 to register your device. We have established a claims processing and support center to assist you. CHEST Issues Joint Statement in Response to Philips Device Recall . How are you removing the old foam safely? Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. At the bottom of this website, click Patient/Device User . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This Alert was related only to Trilogy 100 ventilators that were repaired. 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. How will Philips address this issue? Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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). 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. 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. 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. Koninklijke Philips N.V., 2004 - 2023. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. . However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. This factor does not refer to heat and humidity generated by the device for patient use. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. 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. Please read the Notice carefully. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The company has developed a comprehensive plan for this correction, and has already begun this process. You can access the Philips RS North America webpage by clicking here. For more information about your replacement device including video instructions click here. Additional Resources: Medical Device Recall. 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. How long will it take to address all affected devices? 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). Replace these devices with an unaffected device. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. We thank you for your patience as we work to restore your trust. 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. As a first step, if your device is affected, please start theregistration process here. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. 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 See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. The return shipment for your old device is pre-paid so there is no charge to you. 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. Before sharing sensitive information, make sure you're on a federal government site. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. ~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. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. You can find the list of products that are not affected as part of the corrective actionhere. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Always ensure you are being taken care of, i.e. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . If your ventilator is alarming with a High Priority alarm, you must do the following: 1. 4. If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. 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). The list of, If their device is affected, they should start the. For more information click here. 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. 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. 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. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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 The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. 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. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP, System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series). For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Are you still taking new orders for affected products? For more information on the recall notification for customers, users and physicians, please click here. 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. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. Consult with your physician to determine the benefits of continuing therapy and potential risks. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) are used in clinical environment and home care settings, If the device was not already corrected or replaced through the June 2021 recall. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. Follow those instructions. Can we help? Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series). Is there any possibility others are affected? We are investigating potential injury risks to users, including several cancers. 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 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. 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. 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. This recall notification / field safety notice has not yet been classified by regulatory agencies. Plaintiffsfiled a Second Amended Complaint in November 2022. If your physician determines that you must continue using this device. Updating everyone on what they need to know and do, and to participate in the corrective action. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. 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. The relevant subsidiaries are cooperating with the agency. High heat and high humidity environments may also contribute to foam degradation in certain regions. No further products are affected by this issue. This could affect the prescribed therapy. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. All rights reserved. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). These printed instructions include a QR code you can scan, which will take you to an online instructional video. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. The recall is a high-profile problem that has affected millions of patients in the U.S. and other countries for almost two years, and those . The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. If your physician determines that you must continue using this device, use an inline bacterial filter. Philips Australia will work with your clinical care team to arrange a loan device, where required. We thank you for your patience as we work to restore your trust. 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. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Talk with health care providers to decide if your care and treatment should change as a result of this recall. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. 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. Please note that some people will also receive a copy of the Notice by email or post. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. After registration, we will notify you with additonal information as it becomes available. Philips Quality Management System has been updated to reflect these new requirements. 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. All rights reserved. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Is there a question we can answer for you? 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). This information has not been separately verified by Philips Electronics Australia Ltd. 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. If you do not have this letter, please call the number below. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. All oxygen concentrators, respiratory drug delivery products, airway clearance products. You are about to visit the Philips USA website. Philips Australia will work with your clinical care team to arrange a loan device, where required. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. 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. 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 . 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. 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Contact your clinical care team to determine if a loan device is required. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. What is meant by "high heat and humidity" being one of the causes of this issue? That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. 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. 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. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. 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. How did this happen, and what is Philips doing to ensure it will not happen again? This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. 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. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Select your country. Doing this could affect the prescribed therapy. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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