Plaintiffsfiled a Second Amended Complaint in November 2022. 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. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? In those regions where Philips provides both patient care and devices, will new patients be set up with devices? If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Philips Sleep and respiratory care. 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. This potentially deadly combination . Register your device (s) on Philips' recall website . Was it a design, manufacture, supplier or other problem? Use of these devices may cause serious injuries or death. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. 2. All rights reserved. It includes further information such as what steps are available to Group Members in the class action. 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 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. Are affected devices safe for use? We thank you for your patience as we work to restore your trust. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. 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. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. If separation of the foam from the plastic backing was to occur, to the extent that therapy is impacted, your device will issue a High Priority alarm, either Low Inspiratory Pressure or Circuit Disconnect. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP, System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series). Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. 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. The relevant subsidiaries are cooperating with the agency. However, this new recall does apply to some of the devices recalled . 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. 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. 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. Are affected devices continuing to be manufactured and/or shipped? 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. Do not stop or alter your prescribed ventilator therapy. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. kidneys and liver) and toxic carcinogenic affects. 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 company has developed a comprehensive plan for this correction, and has already begun this process. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Additional Resources: Medical Device Recall. Additionally, the device Instructions for Use provide product identification information to assist with this activity. For more information on the recall notification for customers, users and physicians, please click here. Once you receive your replacement device, you will need to return your old device. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. This Alert was related only to Trilogy 100 ventilators that were repaired. Talk with health care providers to decide if your care and treatment should change as a result of this recall. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. Contact your clinical care team to determine if a loan device is required. Can Philips replace products under warranty or repair devices under warranty? Please note that some people will also receive a copy of the Notice by email or post. This recall notification / field safety notice has not yet been classified by regulatory agencies. For more information click here. Please note, the correction for Trilogy 100 is currently on hold. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Are spare parts currently part of the ship hold? 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. Follow the steps for registering your device. Please note that the information available at these links has not been separately verified by Philips Australia. We have established a claims processing and support center to assist you. We thank you for your patience as we work to restore your trust. Register your device on the Philips recall website or call 1-877-907-7508. The plastic may also cause the machine to fail and stop working suddenly during use. When will the correction for this issue begin? Can we help? Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. . This factor does not refer to heat and humidity generated by the device for patient use. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. After registration, we will notify you with additonal information as it becomes available. All rights reserved. How did this happen, and what is Philips doing to ensure it will not happen again? By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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