Membership. As a first step, if your device is affected, please start the. This information has not been separately verified by Philips Electronics Australia Ltd. Always ensure you are being taken care of, i.e. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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. 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. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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 recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. However, this new recall does apply to some of the devices recalled . 2. Call us at +1-877-907-7508 to add your email. December 2, 2021 (latest update) . Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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). It includes further information such as what steps are available to Group Members in the class action. If you have a secondary back up device, switch over to that device. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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 Australia will work with your clinical care team to arrange a loan device, where required. This Alert was related only to Trilogy 100 ventilators that were repaired. 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). The plastic may also cause the machine to fail and stop working suddenly during use. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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 . You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. 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). Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Before sharing sensitive information, make sure you're on a federal government site. You are about to visit the Philips USA website. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. You are about to visit the Philips USA website. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. For more information on the recall notification for customers, users and physicians, please click here. 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. Philips CPAPs cannot be replaced during ship hold. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. 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. 2. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Click "Next". Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Consult your Instructions for Use for guidance on installation. 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. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. 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. Please note, the correction for Trilogy 100 is currently on hold. Updating everyone on what they need to know and do, and to participate in the corrective action. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. 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). What devices have you already begun to repair/replace? To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected by the corrective action. [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. Plaintiffsfiled a Second Amended Complaint in November 2022. 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. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. Follow the steps for registering your device. * Voluntary recall notification in the US/field safety notice for the rest of the world. (, 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. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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. For any other matters not directly related to Investor Relations, please visit our company contactspage. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. At this time, Philips is unable to set up new patients on affected devices. 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. 1. Selected products A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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). The letter offered the following recommendations. 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 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. When will the correction for this issue begin? 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Please note that the information available at these links has not been separately verified by Philips Australia. . The .gov means its official.Federal government websites often end in .gov or .mil. 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. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. Where do I direct questions about my replacement device? Contact your clinical care team to determine if a loan device is required. 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. 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. Is Philips certain that this issue is limited to the listed devices? Patients who are concerned should check to see if their device is affected by the corrective action. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. We thank you for your patience as we work to restore your trust. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). After registration, we will notify you with additonal information as it becomes available. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 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. 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. - 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. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. 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. Can Philips replace products under warranty or repair devices under warranty? If your ventilator is alarming with a High Priority alarm, you must do the following: 1. After registration, we will notify you with additonal information as it becomes available. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: For patients using life-sustaining mechanical ventilator devices: The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. 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. 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