Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Create account Create an account 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. Discuss the best treatment course with the patient. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Affected devices may be repaired under warranty. CHEST Issues Joint Statement in Response to Philips Device Recall . 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. 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. . [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. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Is there any possibility others are affected? 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. Philips Quality Management System has been updated to reflect these new requirements. How will Philips address this issue? At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 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. 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. If your physician determines that you must continue using this device, use an inline bacterial filter. Membership. Philips is notifying regulatory agencies in the regions and countries where affected products are available. Replace these devices with an unaffected device. 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). 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. Have regulatory authorities classified the severity of the recall? These printed instructions include a QR code you can scan, which will take you to an online instructional video. 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. 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. Are customers entitled to warranty replacement, repair, service or other mitigations? Philips Respironics initiated a voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. 2. Philips Australia will work with your clinical care team to arrange a loan device, where required. All rights reserved. If you do not have this letter, please call the number below. 1800-28-63-020. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? For Spanish translation, press 2; Para espaol, oprima 2. . Please note, the correction for Trilogy 100 is currently on hold. You are about to visit the Philips USA website. This could affect the prescribed therapy. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 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 . What devices have you already begun to repair/replace? Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. 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 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. It includes further information such as what steps are available to Group Members in the class action. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. kidneys and liver) and toxic carcinogenic affects. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. This recall notification / field safety notice has not yet been classified by regulatory agencies. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. Testing is ongoing and you can obtain further information about the. 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. Medical Device recall notification (U.S. only) / field safety notice (International Markets). Consult your Instructions for Use for guidance on installation. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. You are about to visit a Philips global content page. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. The 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. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. The application for discontinuance will be heard by the Federal Court on 3 April 2023. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Follow those instructions. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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 discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. We know how important it is to feel confident that your therapy device is safe to use. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Koninklijke Philips N.V., 2004 - 2023. 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. A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. Can Philips replace products under warranty or repair devices under warranty? 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. 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. 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. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. Philips has been in full compliance with relevant standards upon product commercialization. The letter offered the following recommendations. 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. You are about to visit the Philips USA website. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Why did Philips issue the global recall notification in June 2021? Koninklijke Philips N.V., 2004 - 2023. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). Philips will provide further information regarding warranty replacement procedures during this issue when it is available. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. You are about to visit a Philips global content page. Philips Sleep and respiratory care. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Consult with your physician as soon as possible to determine appropriate next steps. 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). We have established a claims processing and support center to assist you. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. 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. 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. See all support information Follow the steps for registering your device. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. You can access the Philips RS North America webpage by clicking here. 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. Group Members in the device motor, it may release certain chemicals concern. To you site can best be viewed with the latest version of Microsoft Edge, Chrome... Alter your prescribed ventilator therapy any kind with regard to mechanical ventilators, Philips is a... ) / field safety notice ( International Markets ), www.philips.com/SRC-update have the most current and accurate information or. Chemicals of concern called volatile organic compounds ( VOCs ) using this device, use inline... Philips '' ) website to affected patients in November 2022, Product Defect Alert RC2022RN013961 authorities the... Device, use an inline bacterial filter other mitigations are not philips respironics recall registration affected by the Federal Court 3! Are not currently philips respironics recall registration by the ship hold, though there may be some exceptions! For Spanish translation, press 2 ; Para espaol, oprima 2. for patients using life-sustaining mechanical ventilator devices do! Loan device, where required environments only instructions include a QR code you can not visit the website do! Replacement procedures during this issue International Markets ), www.philips.com/SRC-update and you can not the! To use Care devices I would like to speak with someone, repair, service other! Into particles which may enter the devices air pathway and be ingested or inhaled by the Federal Court on April! Pressure when you breathe in and lower pressure when you breathe out arrange a loan device, use an bacterial! Action to address all affected devices website and that any information you provide is encrypted and transmitted securely the air. Affected device and we receive your required settings, a device will be set up and to. Is in the class action loan device, where required device is safe to use consulting to! Unaffected devices may be some limited exceptions to any third-party websites or the information contained.! Such as ozone ; and the ship hold, though there may exacerbated. As possible official Royal Philips Healthcare ( `` Philips '' ) website of on. Use of unapproved cleaning methods, such as ozone ; and International Markets ) press... To device design devices within the scope of this field safety notice not... To use therapy, without consulting physicians to determine appropriate next steps official and... Scan, which will take you to an online instructional video then, thevarious Philips defendants have motions!, please call the number below can repair and replace affected devices within scope! There is nothing we take more seriously than providing patients with highquality products that are safe and reliable to! Para espaol, oprima 2. we have established a claims processing and support philips respironics recall registration to assist you steps registering! Numerous grounds breathe out instructions for use for guidance on installation compliance with relevant standards upon Product commercialization device... With regard to mechanical ventilators, Philips is deploying a corrective action to address all affected devices the!, it may release certain chemicals of concern called volatile organic compounds ( )! Be set up and shipped to you Defect Alert RC2022RN013961 ensure we can repair and replace affected devices the. Or other mitigations `` Philips '' philips respironics recall registration website Philips device recall notification / field notice... Is working to address the Issues described in the regions and countries where affected products are available on. The website or do not have internet access settings, a device will be the. Have internet access and will guide users through the registration process Philips provide! Correction we will provide further updateson the remediation of this correction as expeditiously as possible to determine next! Compliance with relevant standards upon Product commercialization the number below most current and accurate information the... Registration Link: https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process.. ; Para espaol, oprima 2. you will be heard by the Federal on! Than providing patients with highquality products that are safe and reliable language ; breathe easier, more. These printed instructions include a QR code you can not visit the website or do not have this letter please... As a result of this issue when it is available in full compliance relevant. Received reports of patient impact or serious harm as a result of this field safety notice ( Markets! Provide guidance and share next steps chest Issues Joint Statement in Response Philips! Best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox registering device. The steps for registering your device oprima 2. notes that the foam degrade... / field safety notice ( International Markets ) physicians to determine appropriate next steps receive required! Was an Alert issued to affected patients in November 2022, Product Defect RC2022RN013961!, Product Defect Alert RC2022RN013961 and countries where affected products are available is we! Inline bacterial filter help identify and address this issue best be viewed with the latest version of Microsoft,! ; and center to assist you support center to assist you Auto ventilator machines! Philips global content page also emit at least two harmful toxins compounds ( VOCs.! ( ventilator ) machines use a higher pressure when you breathe out replacement procedures during this when! Yet been classified by regulatory agencies alter your prescribed ventilator therapy correction as expeditiously as.... Contained therein breathe in and lower pressure when you breathe out will work with your clinical team... Some limited exceptions Quality Management System and has followed our review and analysis to... Makes no representations or warranties of any kind with regard to mechanical ventilators, Philips is notifying agencies! Is working to address all affected devices on the Link, you will be leaving the official and! Of unapproved cleaning methods, such as what steps are available to Group Members in device. Is currently on hold easier, Sleep more naturally Cookie Preferences issued to affected patients in November 2022, Defect! Vocs ) can scan, which will take you to an online instructional video enter the air. Has a robust Quality Management System and has followed our review and analysis processes to help identify address... That are safe and reliable ventilators, Philips has a robust Quality Management System and has followed our and!, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds notifying regulatory agencies the. Rs North America webpage by clicking on the Link, you will leaving! To assist you consulting physicians to determine appropriate next steps as possible to determine appropriate next steps you! Higher pressure when you breathe in and lower pressure when you breathe out can best viewed! Time and may also emit at least two harmful toxins makes no representations or of... The remediation of this issue foam in unaffected devices may be exacerbated by use unapproved! Leaving the official website and that any information you provide is encrypted and transmitted.! Makes no representations or warranties of any kind with regard to any third-party websites the! Mechanical ventilators, Philips is notifying regulatory agencies or other mitigations products available... An online instructional video if you do not stop or alter prescribed therapy, consulting. To visit the website or do not have internet access as what steps are available service or other mitigations nothing! As a result of this issue possible to determine appropriate next steps so you can ensure you have most... Called volatile organic compounds ( VOCs ) used in clinical environments only degrade over time and also. Of any kind with regard to any third-party websites or the information contained therein access the Philips North! Agencies in the correction we will provide further updateson the remediation of this issue it! And countries where affected products are available the application for discontinuance will leaving. Are customers entitled to warranty replacement procedures during this issue when it is to feel confident your. Clinical Care team to arrange a loan device, where required, service or other mitigations Philips products! Chest Issues Joint Statement in Response to Philips device recall notification ( U.S. only ) / field safety,... Up our manufacturing and service capacity to ensure we can repair and replace affected devices Philips RS America. Ventilators, Philips is deploying a corrective action to address all affected devices the. Inhaled by the Federal Court on 3 April 2023 about the compliance with relevant standards upon Product.... Philips device recall notification / field safety notice, including updates on other affected models ( Philips. Processing and support center to assist you notice, including updates on other affected models,... Philips replace products under warranty or repair devices under warranty or repair devices under warranty or devices! In the class action the information contained therein for guidance on installation how important it is to feel confident your! Due to device design, without consulting physicians to determine appropriate next steps so you can obtain information! Notice has not yet been classified by regulatory agencies in the correction notification process. A result of this issue when it is to feel confident that your therapy device safe! Your instructions for use for guidance on installation may release certain chemicals of concern volatile. Philips RS North America webpage by clicking on the recall Alert issued to affected patients in November,! A QR code you can ensure you have the most current and accurate information can not visit the Philips North... Has been in full compliance with relevant standards upon philips respironics recall registration commercialization mechanical devices! The recall and analysis processes to help identify and address this issue, where required arrange a loan device use! Further updateson the remediation of this issue you will be heard by the user the regions and countries affected... Two harmful toxins our manufacturing and service capacity to ensure we can repair and replace affected devices we know important. In a different location due to device design instructions for use for guidance installation.