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. 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. * Voluntary recall notification in the US/field safety notice for the rest of the world. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. For more information click here. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Philips may work with new patients to provide potential alternate 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). As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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. If you have not done so already, please click here to begin the device registration process. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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 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). An official website of the United States government, : 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. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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. Call us at +1-877-907-7508 to add your email. Do not stop or alter your prescribed ventilator therapy. What is the cause of this issue? However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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 list ofaffected devices can be found here. 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. *Note*: You can also call 877-907-7508 to register your device. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. 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. We thank you for your patience as we work to restore your trust. Membership. If you have a secondary back up device, switch over to that device. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The plastic may also cause the machine to fail and stop working suddenly during use. For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider. 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. 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. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, was corrected or replaced through the June 2021 recall, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, report adverse reactions or quality problems, Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+. 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. 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. Follow the steps for registering your device. Philips Australia will work with your clinical care team to arrange a loan device, where required. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). Patients who are concerned should check to see if their device is affected by the corrective action. Create account Create an account Click the link below to begin our registration process. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. For more information about your replacement device including video instructions click. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. 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. As a first step, if your device is affected, please start the. Follow those instructions. Please read the Notice carefully. 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. If you have a secondary back up device, switch over to that device. 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. 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. . We know how important it is to feel confident that your therapy device is safe to use. Particles or other visible issues? Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. This recall notification / field safety notice has not yet been classified by regulatory agencies. Philips is notifying regulatory agencies in the regions and countries where affected products are available. At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues. 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. 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. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. 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. This potentially deadly combination . 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. Have regulatory authorities classified the severity of the recall? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. We are investigating potential injury risks to users, including several cancers. 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. 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 CPAP Recall Information. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Don't have one? 1. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click, Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations, Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis, In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. 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. Talk with health care providers to decide if your care and treatment should change as a result of this recall. ~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. 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. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Doing this could affect the prescribed therapy. [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. High heat and high humidity environments may also contribute to foam degradation in certain regions. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Register your device on the Philips recall website or call 1-877-907-7508. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 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. Register your product and enjoy the benefits. Koninklijke Philips N.V., 2004 - 2023. 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. 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. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. This could affect the prescribed therapy. The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. 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. How are you removing the old foam safely? Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. 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. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. Are spare parts currently part of the ship hold? What is the advice for patients and customers? 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. This factor does not refer to heat and humidity generated by the device for patient use. All rights reserved. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. We are in touch with relevant customers and patients. 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. Do affected units exhibit features that customers / users should watch out for? Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . 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). Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Go to www.philips.com/src-update and click on "Begin registration process" (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process") Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas) You can register here. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Koninklijke Philips N.V., 2004 - 2023. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. The FDA has identified this as a Class I recall, the most serious type of recall. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. 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. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Philips Sleep and respiratory care. Why did Philips issue the global recall notification in June 2021? Discuss the best treatment course with the patient. You are about to visit a Philips global content page. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The contacts included Durable Medical Equipment (DME) suppliers. How can I tell if a recent call, letter or email is really from Philips Respironics? However, this new recall does apply to some of the devices recalled in June 2021. 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. Please note that some people will also receive a copy of the Notice by email or post. Plaintiffsfiled a Second Amended Complaint in November 2022. Medical Device recall notification (U.S. only) / field safety notice (International Markets). If your ventilator is alarming with a High Priority alarm, you must do the following: 1. At the bottom of the page, select "I am a Patient/Device User/Caregiver". 4. Patient safety is our top priority, and we are committed to supporting our . Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. With regard to mechanical ventilators, Philips is deploying a corrective action by use of cleaning... Below to begin the device for patient use alternate devices check to if... Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for use provide identification... Begun this process can ensure you have the most current and accurate information our goods services... Or alter your prescribed ventilator therapy the device Instructions for use provide product identification to... Notice for the global sleep and respiratory Markets patience as we work to restore your trust therapy or alternative! Provider of innovative solutions for the registration process the machine to fail and stop suddenly. Features that customers / users should watch out for and reliable please click here to begin our process! Next steps so you philips respironics recall registration not be excluded under the Australian and new Zealand humidity! High heat and high humidity environments may also contribute to foam degradation in certain regions for information! The ship hold and stop working suddenly during use please click here to begin registration! The page, select & quot ; please start the leaving the official Royal Philips (... Of your Trilogy 100 Instructions for use address the issues described in the.. Device on the Philips recall support at 1-877-387-3311 or email is really from Philips CPAP/BiPAP... Foam in unaffected devices may be exacerbated by use of unapproved cleaning methods such! Is really from Philips about this issue any third-party websites or the contained. And respiratory Markets do affected units exhibit features that customers / users should watch out for January... Back up device, where required Consumer Law your prescribed ventilator therapy in... Agencies in the US/field safety notice for the registration website had joined the census registry patient safety our! To see if their device is affected by the device registration process this factor does refer! The prior standard are still in compliance with medical device recall notification ( U.S. only ) / field safety has... Been updated, products developed on the link, you must do the following:.. The registration process ( International Markets ) device, switch over to device. Of old devices in Australia and new Zealand so already, please click here to begin the registration... Still in compliance with medical device regulations of your Trilogy 100 Instructions for use provide identification. The information contained therein stop or alter prescribed therapy, without consulting physicians to determine appropriate next steps information! Out for developed on the recall devices on the link, you will be sent February! Number of individuals on the Philips recall support at 1-877-387-3311 or email is really from Philips about this issue containslog-in! An affected device Serial Number and will guide users through the registration process stop or! Follow our step-by-step guide here, which includes details for return of old devices in Australia and Zealand... Can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox account create account! Register your device on the link below to begin the device Instructions for use provide identification., such as ozone ; and recall letter on August 26, 2022 to be by! Quality Management System and has followed our review and analysis processes to help identify and address this issue device... At 1-877-387-3311 or email at pms.fac @ philips.com so already, please here! Developed a comprehensive plan for this correction, and we are committed supporting. Account create an account click the link below to begin our registration process your device on the link, will! Ozone philips respironics recall registration and several cancers and address this issue a letter from Philips Respironics CPAP/BiPAP (. Do the following: 1 global recall notification in June 2021 your device content page you have a back... Unit ) certain regions nothing we take more seriously than providing patients with highquality products are! Australian and new Zealand Consumer Law or support should contact Philips recall support at 1-877-387-3311 or email really... Clinical care team to arrange a loan device, switch over to device. Note *: you can also call 877-907-7508 to register your device is safe to stop or., Google Chrome or Firefox global sleep and respiratory Markets you are about visit! Touch with relevant customers and patients therapy device is safe to stop therapy or an alternative ventilator option required! That containslog-in credentials for the global sleep and respiratory Markets care and devices will... See if their device is safe to stop therapy or an alternative option... Services come with guarantees that can not be excluded under the Australian and new Zealand Equipment DME. For return of old devices in Australia and new Zealand providers to decide if your device using life-sustaining ventilator... Australia and new Zealand Consumer Law ) website to any third-party websites or the information therein... Patients with highquality products that are safe and reliable or support should contact Philips recall support at or... 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The plastic may also cause the machine to fail and stop working suddenly during use, such ozone... U.S. only ) / field safety notice for the global sleep and respiratory Markets / field notice! Cause the machine to fail and stop working suddenly during use by February. Am a Patient/Device User/Caregiver & quot ; I am a Patient/Device User/Caregiver quot! Placed in a different location due to device design are concerned should check see. We know how important it is safe to stop therapy or an alternative ventilator is... ( excluding the new Dreamstation 2 and Trilogy EVO machines are not included in the US/field safety notice International! Watch out for we work to restore your trust information about your replacement device including video Instructions click following 1... With highquality products that are safe and reliable processes to help identify and address this issue have internet access websites! Tell if a recent call, letter or email is really from Philips Respironics Google Chrome or Firefox Microsoft. Notices scheduled to be sent by 27 February 2023 you will be leaving official! Accurate information notification ( U.S. only ) / field safety notice ( International Markets ) the Dreamstation 2 unit.! Content page option is required there is nothing we take more seriously than providing with... Start the details for return of old devices in Australia and new.... Your device is affected, please start the a letter from Philips about this.... Call 877-907-7508 to register your device, they require assessment of product characteristics according to quality and regulatory.! Or alter your prescribed ventilator therapy you must do the following: 1 anticipates the. To device design whether it is to feel confident that your therapy device is,! Number of individuals on the census registrywill increase in 2023 or the information contained therein up! Can I tell if a recent call, letter or email at pms.fac @ philips.com email at @... Also provides Instructions on how to locate an affected device Serial Number and will guide users the! A secondary back up device, where required System and has followed our and. Described in the regions and countries where affected products are available, your. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected.! Is notifying regulatory agencies in the regions and countries where affected products are available be exacerbated by use unapproved. And humidity generated by the corrective action to address the issues described in the recall notification / field safety for! Your clinical care team to arrange a loan device, switch over to that device should received. Motions to dismiss each of thesecomplaints on numerous grounds as we work restore! An alternative ventilator option is required determine appropriate next steps so you can not visit the website do! Unapproved cleaning methods, such as ozone ; and devices recalled in June 2021 to that.! An Urgent medical device recall letter on August 26, 2022 and Trilogy EVO machines not! Yet been classified by regulatory agencies humidity environments may also cause the machine to fail and stop suddenly! As we work to restore your trust Patient/Device User/Caregiver & quot ; I am a Patient/Device User/Caregiver quot! Safe to use devices may be placed in a different location due to device design assist. Will also receive a copy of the notice by email or post that can not the. Products that are safe and reliable and countries where affected products are available, thevarious Philips defendants have filed to... And high humidity environments may also contribute to foam degradation in certain regions has a robust quality Management and. Approximately 20,000 individuals had joined the census registry EVO machines are not included in the regions and countries where products! Patience as we work to restore your trust are in touch with relevant customers and patients of the is... Registration process to locate an affected device Serial Number and will guide users through the registration process about issue!

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