We thank you for your patience as we work to restore your trust. For more information click here. The return shipment for your old device is pre-paid so there is no charge to you. 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. Don't have one? 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. 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. 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. Can Philips replace products under warranty or repair devices under warranty? Before sharing sensitive information, make sure you're on a federal government site. We thank you for your patience as we work to restore your trust. The list ofaffected devices can be found here. 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). Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. Do affected units exhibit features that customers / users should watch out for? 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 . Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. (, 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. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Use of these devices may cause serious injuries or death. All rights reserved. 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. 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. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. 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. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. 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. 1. This factor does not refer to heat and humidity generated by the device for patient use. 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. How it works. 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). It includes further information such as what steps are available to Group Members in the class action. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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 Sleep and respiratory care. Talk with health care providers to decide if your care and treatment should change as a result of this recall. Please note that the information available at these links has not been separately verified by Philips Australia. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. If you have a secondary back up device, switch over to that device. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. 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. As a first step, if your device is affected, please start the. 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. 2. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. 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. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. However, this new recall does apply to some of the devices recalled in June 2021. 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. 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. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Are customers entitled to warranty replacement, repair, service or other mitigations? Philips has been in full compliance with relevant standards upon product commercialization. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Philips may work with new patients to provide potential alternate devices. 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. What happens after I register my device, and what do I do with my old device? 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. How did this happen, and what is Philips doing to ensure it will not happen again? Koninklijke Philips N.V., 2004 - 2023. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: 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. 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. Register your device (s) on Philips' recall website . Only machines with serial numbers identified in the companys communications are affected by this recall. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. . 3. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. You are about to visit a Philips global content page. - 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. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. If you have not done so already, please click here to begin the device registration process. As part of the notification process, customers and patients will be provided with more information on the next steps to implement the solution as it becomes available. Medical Device recall notification (U.S. only) / field safety notice (International Markets). This could affect the prescribed therapy. Are affected devices continuing to be manufactured and/or shipped? If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. 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. Click "Next". 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. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. For any other matters not directly related to Investor Relations, please visit our company contactspage. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. (0044) 20 8089 3822 Physicians and other medical care providers This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. What is meant by "high heat and humidity" being one of the causes of this issue? 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. The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. Please note, the correction for Trilogy 100 is currently on hold. 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. 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. At the bottom of this website, click Patient/Device User . By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Consult your Instructions for Use for guidance on installation. Royal Philips (NYSE: PHG) is promising a turnaround from its bottom-line woes, which began with one of the largest medical devices recalls in recent history. Affected devices may be repaired under warranty. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Create account Create an account Is there any possibility others are affected? All rights reserved. At this time, Philips is unable to set up new patients on affected devices. At this time, Philips is unable to set up new patients on affected devices. 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. 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. Has Philips received any reports of patient harm due to this issue? Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. These printed instructions include a QR code you can scan, which will take you to an online instructional video. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). The letter offered the following recommendations. After registration, we will notify you with additonal information as it becomes available. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. [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. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. To register your product, you'll need to log into you're my Philips account. 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. We thank you for your patience as we work to restore your trust. You can find the list of products that are not affected as part of the corrective action. 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. 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 .gov means its official.Federal government websites often end in .gov or .mil. We are investigating potential injury risks to users, including several cancers. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 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. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. You can find the list of products that are not affected as part of the corrective actionhere. For Spanish translation, press 2; Para espaol, oprima 2. . This Alert was related only to Trilogy 100 ventilators that were repaired. You are about to visit the Philips USA website. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. This Alert was related only to Trilogy 100 ventilators that were repaired. Is there a question we can answer for you? There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. An official website of the United States government, : Membership. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Is Philips certain that this issue is limited to the listed devices? Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. Always ensure you are being taken care of, i.e. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). . At this time, affected devices are on manufacturing and ship hold. We thank you for your patience as we work to restore your trust. 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. 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. Register your device at the Phillips Respironics website (link below). 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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 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 have established a claims processing and support center to assist you. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. December 2, 2021 (latest update) . Can I trust the new foam? As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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 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. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Are spare parts currently part of the ship hold? Please read the Notice carefully. 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. 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. Please note that the information available at these links has not been separately verified by Philips Australia. 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