Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. 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. The recall includes many mechanical ventilator . We thank you for your patience as we work to restore your trust. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Follow the steps for registering your device. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. 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. At the bottom of the page, select "I am a Patient/Device User/Caregiver". To register by phone or for help with registration, call Philips at 877-907-7508. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. On June 14, Philips issued a recall for many of its CPAP, BiPAP and ventilator machines because of concerns that users may inhale small particles of the foam used to dampen sound while the machines are in use. Philips Sleep and respiratory care. 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. Philips Sleep and respiratory care. Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. 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. Patient safety is our top priority, and we are committed to supporting our . Use of these devices may cause serious injuries or death. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. Please note that some people will also receive a copy of the Notice by email or post. For Spanish translation, press 2; Para espaol, oprima 2. . On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. 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 makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For more information on the recall notification for customers, users and physicians, please click here. We thank you for your patience as we work to restore your trust. The return shipment for your old device is pre-paid so there is no charge to you. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 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. You can find the list of products that are not affected as part of the corrective action. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. 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. 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. 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). 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. Images may vary. We thank you for your patience as we work to restore your trust. 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. Consult with your physician to determine the benefits of continuing therapy and potential risks. 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. The following products listed are affected by the correction: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Information for Trilogy 100 patients with a repaired device. Do not stop or alter your prescribed ventilator therapy. 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. Create account Create an account 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 . 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 follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Contact your clinical care team to determine if a loan device is required. Is this a recall? 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 more information about your replacement device including video instructions click. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. Discuss the best treatment course with the patient. Replace these devices with an unaffected device. Philips CPAPs cannot be replaced during ship hold. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. This could affect the prescribed therapy. The relevant subsidiaries are cooperating with the agency. [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. You can access the Philips RS North America webpage by clicking here. 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. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. At this time, Philips is unable to set up new patients on affected devices. Testing is ongoing and you can obtain further information about the. If your physician determines that you must continue using this device. Why did Philips issue the global recall notification in June 2021? To date, Philips has not received reports of patient impact or serious harm as a result of this issue. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. 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. Once you receive your replacement device, you will need to return your old device. 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. 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. We have established a claims processing and support center to assist you. Is there any possibility others are affected? In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. However, this new recall does apply to some of the devices recalled . This information has not been separately verified by Philips Electronics Australia Ltd. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. As a first step, if your device is affected, please start the. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 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. Register your device on the Philips recall website or call 1-877-907-7508. 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. If their device is affected, they should start theregistration process here. Has Philips received any reports of patient harm due to this issue? This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. 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. 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. Call us at +1-877-907-7508 to add your email. 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 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. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. Doing this could affect the prescribed therapy. You can register here. Are affected devices being replaced and/or repaired? 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 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. What is the safety hazard associated with this issue? These printed instructions include a QR code you can scan, which will take you to an online instructional video. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Can I trust the new foam? 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. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Click the link below to begin our registration process. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. Koninklijke Philips N.V., 2004 - 2023. 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