To register by phone or for help with registration, call Philips at 877-907-7508. 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. 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. 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. At this time, affected devices are on manufacturing and ship hold. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Only machines with serial numbers identified in the companys communications are affected by this recall. The new material will also replace the current sound abatement foam in future products. kidneys and liver) and toxic carcinogenic affects. Call us at +1-877-907-7508 to add your email. Testing is ongoing and you can obtain further information about the. 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). Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. kidneys and liver) and toxic carcinogenic affects. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. Please note that the information available at these links has not been separately verified by Philips Australia. The new material will also replace the current sound abatement foam in future products. Particles or other visible issues? The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. This Notice is not a communication issued by Philips in relation to the remediation of your device or 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. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. 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 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. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. We have established a claims processing and support center to assist you. Please note that the information available at these links has not been separately verified by Philips Australia. . This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen; The return shipment for your old device is pre-paid so there is no charge to you. In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (International markets) / voluntary recall notification (U.S. only). The FDA has identified this as a Class I recall, the most serious type of recall. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. Register your device on the Philips recall website or call 1-877-907-7508. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 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. 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. Philips CPAPs cannot be replaced during ship hold. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please read the Notice carefully. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. The device types are: 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. 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. No further products are affected by this issue. All rights reserved. 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. Patients who are concerned should check to see if their device is affected by the corrective action. Should affected devices be removed from service? 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? 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 that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). Talk with health care providers to decide if your care and treatment should change as a result of this recall. 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 . The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 3. 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. 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. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Consult with your physician to determine the benefits of continuing therapy and potential risks. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Was it a design, manufacture, supplier or other problem? If your physician determines that you must continue using this device, use an inline bacterial filter. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. For more information about your replacement device including video instructions click here. 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. We thank you for your patience as we work to restore your trust. Plaintiffsfiled a Second Amended Complaint in November 2022. As a first step, if your device is affected, please start theregistration process here. We thank you for your patience as we work to restore your trust. 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. 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. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. When will the correction for this issue begin? If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. 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). This factor does not refer to heat and humidity generated by the device for patient use. You are about to visit the Philips USA website. Are customers entitled to warranty replacement, repair, service or other mitigations? 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. Are affected devices safe for use? 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. Membership & Community. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. All rights reserved. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). 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. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. 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. At this time, Philips is unable to set up new patients on affected devices. Philips may work with new patients to provide potential alternate devices. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Click the link below to begin our registration process. For more information on the recall notification for customers, users and physicians, please click here. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. 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. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Are spare parts currently part of the ship hold? Are affected devices being replaced and/or repaired? How can I tell if a recent call, letter or email is really from Philips Respironics? The relevant subsidiaries are cooperating with the agency. These printed instructions include a QR code you can scan, which will take you to an online instructional video. If you do not have this letter, please call the number below. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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