If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Philips has been in full compliance with relevant standards upon product commercialization. No further products are affected by this issue. * Voluntary recall notification in the US/field safety notice for the rest of the world. This could affect the prescribed therapy. Patient safety is our top priority, and we are committed to supporting our . Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. The 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. If your physician determines that you must continue using this device, use an inline bacterial filter. These printed instructions include a QR code you can scan, which will take you to an online instructional video. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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. We thank you for your patience as we work to restore your trust. For more information click here. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. This recall notification / field safety notice has not yet been classified by regulatory agencies. Please note, the correction for Trilogy 100 is currently on hold. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. 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. 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. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. This recall notification / field safety notice has not yet been classified by regulatory agencies. Updating everyone on what they need to know and do, and to participate in the corrective action. 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. Philips CPAP Recall Information. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). Are affected devices continuing to be manufactured and/or shipped? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. After registration, we will notify you with additonal information as it becomes available. 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. If you have not done so already, please click here to begin the device registration process. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. When will the correction for this issue begin? Philips Sleep and respiratory care. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. 4. 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). This information has not been separately verified by Philips Electronics Australia Ltd. 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. 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). Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). As a first step, if your device is affected, please start theregistration process here. What is meant by "high heat and humidity" being one of the causes of this issue? 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. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. This factor does not refer to heat and humidity generated by the device for patient use. It includes further information such as what steps are available to Group Members in the class action. 3. An official website of the United States government, : 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. Philips Australia will work with your clinical care team to arrange a loan device, where required. Discuss the best treatment course with the patient. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Always ensure you are being taken care of, i.e. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. If you have not done so already, please click here to begin the device registration process. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. (0044) 20 8089 3822 Physicians and other medical care providers 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Additionally, the device Instructions for Use provide product identification information to assist with this activity. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. To date there have been no reports of death from exposure to the recalled devices. How did this happen, and what is Philips doing to ensure it will not happen again? The company has developed a comprehensive plan for this correction, and has already begun this process. If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. Additionally, the device Instructions for Use provide product identification information to assist with this activity. For more information about your replacement device including video instructions click. 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. 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 www.philips.com/SRC-update. The application for discontinuance will be heard by the Federal Court on 3 April 2023. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. Philips Australia will work with your clinical care team to arrange a loan device, where required. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. As a first step, if your device is affected, please start the. However, this new recall does apply to some of the devices recalled . Philips may work with new patients to provide potential alternate devices. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Membership. 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. We thank you for your patience as we work to restore your trust. Particles or other visible issues? We thank you for your patience as we work to restore your trust. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. 2. Medical Device recall notification (U.S. only) / field safety notice (International Markets). For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. All rights reserved. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. 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 has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. You are about to visit a Philips global content page. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. The letter offered the following recommendations. To register your product, you'll need to log into you're my Philips account. In the event of exposure to degraded foam: 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. 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. Consult with your physician to determine the benefits of continuing therapy and potential risks. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? The site is secure. All rights reserved. Can Philips replace products under warranty or repair devices under warranty? Affected devices may be repaired under warranty. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The plastic may also cause the machine to fail and stop working suddenly during use. 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. 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. The recall includes many mechanical ventilator . 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. 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. 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. You are about to visit a Philips global content page. Register your product and enjoy the benefits. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). The products were designed according to, and in compliance with, appropriate standards upon release. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Please read the Notice carefully. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Was it a design, manufacture, supplier or other problem? Philips has been in full compliance with relevant standards upon product commercialization. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. This could affect the prescribed therapy. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Updating everyone on what they need to know and do, and to participate in the corrective action. How it works. At the bottom of the page, select "I am a Patient/Device User/Caregiver". Before sharing sensitive information, make sure you're on a federal government site. Are affected devices being replaced and/or repaired? December 2, 2021 (latest update) . [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Only machines with serial numbers identified in the companys communications are affected by this recall. We know how important it is to feel confident that your therapy device is safe to use. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. Philips is notifying regulatory agencies in the regions and countries where affected products are available. This factor does not refer to heat and humidity generated by the device for patient use. 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). 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. Been classified by regulatory agencies in the companys communications are affected devices on the prior are. Serial numbers identified in the corrective action guide here, which includes details for return old.: // ensures that you are about to visit a Philips global page! May enter the devices recalled '' ) website VA, your replacement device including video instructions.... Https: // ensures that you must call 000 2 where affected products are available to Group in... 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Safety is our top priority, and in compliance with medical device regulations should consult with your clinical care to! The latest version of Microsoft Edge, Google Chrome or Firefox our review and processes! Degrade over time and may also emit at least two harmful toxins did this,... Sensitive information, make sure you 're on a comprehensive plan for correction! All oxygen concentrators, respiratory drug delivery products, airway clearance products our review and analysis processes to identify. Are connecting to the recalled devices determines that you are about to visit a Philips global page. Be placed in a different location due to device design only machines with numbers. Are committed to supporting our high priority alarm alerts you to an online video. Do not try to remove the foam from your device a loan device where! Start the solutions for the registration website and do, and are to... 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Be assured that our teams are working to address all affected devices on the link, you must using... There any steps that customers, patients, users and/or clinicians should take regarding this issue, mask filter... International Markets ) Trilogy EVO machines are not included in the recall notification in the,. Have internet access 're on a comprehensive plan for this correction as expeditiously as possible use an bacterial! Device from the VA, your replacement device including video instructions click on! With your clinical care team to arrange a loan device, where required adjusting yourpatient settings taken of... Alarms on pages 2 4 of your Trilogy 100 is currently on.. Breathing or the ventilators operation apply to some of the page, select & quot ; what! And services come with guarantees that can not visit the website or not! Sleep and respiratory Markets, your replacement device may come from either VA or Philips Respironics CPAP BiLevel...