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. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. Don't have one? Membership. Koninklijke Philips N.V., 2004 - 2023. You are about to visit the Philips USA website. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. 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. You are about to visit a Philips global content page. 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. See all support information If you have a secondary back up device, switch over to that device. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. kidneys and liver) and toxic carcinogenic affects. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. Are spare parts currently part of the ship hold? [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. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a claim if their unit is affected. Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. Philips Sleep and respiratory care. 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. 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. 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. 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). For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. High heat and high humidity environments may also contribute to foam degradation in certain regions. You are about to visit the Philips USA website. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. 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. Are there any steps that customers, patients, and/or users should take regarding this issue? 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. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. 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. All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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. Koninklijke Philips N.V., 2004 - 2023. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 1800-28-63-020. These printed instructions include a QR code you can scan, which will take you to an online instructional video. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. We have established a claims processing and support center to assist 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. For Spanish translation, press 2; Para espaol, oprima 2. . Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. This Alert was related only to Trilogy 100 ventilators that were repaired. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. 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 If your physician determines that you must continue using this device, use an inline bacterial filter. Where do I direct questions about my replacement device? When will the correction for this issue begin? Philips Sleep and respiratory care. You are about to visit the Philips USA website. For more information about your replacement device including video instructions click. The device types are: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) For patients who registered their DreamStation Go, Philips Australia commenced the replacement program for DreamStation Go devices in December 2022 and it will continue into Q1 2023. Overview. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. For any other matters not directly related to Investor Relations, please visit our company contactspage. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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 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. 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. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Leandro Mazzoni Head of Investor Relations, Rashiq Muhaimen Investor Relations Manager ESG related topics, Investor Relations Manager ESG related topics, Monique van der Heiden Corporate Access Manager. 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. All patients who register their details will be provided with regular updates. 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: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Can Philips replace products under warranty or repair devices under warranty? Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. No further products are affected by this issue. 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. 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. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. We thank you for your patience as we work to restore your trust. The products were designed according to, and in compliance with, appropriate standards upon release. 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. Plaintiffsfiled a Second Amended Complaint in November 2022. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. Please note that some people will also receive a copy of the Notice by email or post. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. 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. [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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. CHEST MEMBERSHIP About Membership . Call 1800-28-63-020 if you cannot visit the website or do not have internet access. How did this happen, and what is Philips doing to ensure it will not happen again? 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. 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. This information has not been separately verified by Philips Electronics Australia Ltd. We thank you for your patience as we work to restore your trust. However, this new recall does apply to some of the devices recalled . 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. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please read the Notice carefully. As a first step, if your device is affected, please start theregistration process here. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. The application for discontinuance will be heard by the Federal Court on 3 April 2023. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? 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). Discuss the best treatment course with the patient. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. The list of, If their device is affected, they should start the. 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. 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. Consult with your physician as soon as possible to determine appropriate next steps. Philips is notifying regulatory agencies in the regions and countries where affected products are available. If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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. 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