This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Always ensure you are being taken care of, i.e. 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. 4. If you have not done so already, please click here to begin the device registration process. Are affected devices safe for use? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. Why did Philips issue the global recall notification in June 2021? 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Follow those instructions. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. Discuss the best treatment course with the patient. What devices have you already begun to repair/replace? 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. Please note that some people will also receive a copy of the Notice by email or post. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Please read the Notice carefully. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. 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. 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. We thank you for your patience as we work to restore your trust. 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. For any other matters not directly related to Investor Relations, please visit our company contactspage. The complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall, In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending, In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. 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. 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. This potentially deadly combination . Doing this could affect the prescribed therapy. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. *Note*: You can also call 877-907-7508 to register your device. Are there any steps that customers, patients, and/or users should take regarding this issue? 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. We know how important it is to feel confident that your therapy device is safe to use. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Plaintiffsfiled a Second Amended Complaint in November 2022. 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. 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). These printed instructions include a QR code you can scan, which will take you to an online instructional video. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Philips may work with new patients to provide potential alternate devices. Koninklijke Philips N.V., 2004 - 2023. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Talk with health care providers to decide if your care and treatment should change as a result of this recall. 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. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. Plaintiffsfiled a Second Amended Complaint in November 2022. Testing is ongoing and you can obtain further information about the. Consult your Instructions for Use for guidance on installation. 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). Philips Quality Management System has been updated to reflect these new requirements. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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. Is there a question we can answer for you? You can find the list of products that are not affected as part of the corrective actionhere. To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected by the corrective action. Philips has been in full compliance with relevant standards upon product commercialization. We thank you for your patience as we work to restore your trust. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. 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. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 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. Are affected devices continuing to be manufactured and/or shipped? How long will it take to address all affected devices? 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. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. 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