Are customers entitled to warranty replacement, repair, service or other mitigations? 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. Replace these devices with an unaffected device. Philips Quality Management System has been updated to reflect these new requirements. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 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. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. If their device is affected, they should start theregistration process here. Royal Philips (NYSE: PHG) is promising a turnaround from its bottom-line woes, which began with one of the largest medical devices recalls in recent history. 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. If you have not done so already, please click here to begin the device registration process. You are about to visit a Philips global content page. The company has developed a comprehensive plan for this correction, and has already begun this process. We are in touch with relevant customers and patients. 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. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. 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. Should affected devices be removed from service? Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. As a first step, if your device is affected, please start the. Consult with your physician as soon as possible to determine appropriate next steps. We thank you for your patience as we work to restore your trust. 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. 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. December 2, 2021 (latest update) . This factor does not refer to heat and humidity generated by the device for patient use. 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. 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. Distribution Dates: August 6, 2020, to September 1, 2021, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Are you still taking new orders for affected products? This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. 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. 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. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Patients who are concerned should check to see if their device is affected by the corrective action. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 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. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). 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. 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. 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. In the event of exposure to chemical emissions: 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. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Use of these devices may cause serious injuries or death. Please note that some people will also receive a copy of the Notice by email or post. kidneys and liver) and toxic carcinogenic affects. 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. 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. At this time, Philips is unable to set up new patients on affected devices. Follow those instructions. 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. Is this a recall? As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. What is the advice for patients and customers? The FDA has identified this as a Class I recall, the most serious type of recall. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. Doing this could affect the prescribed therapy. Koninklijke Philips N.V., 2004 - 2023. 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. 3. 3. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). * Voluntary recall notification in the US/field safety notice for the rest of the world. 4. Register your device (s) on Philips' recall website . Always ensure you are being taken care of, i.e. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Don't have one? You are about to visit a Philips global content page. When will the correction for this issue begin? 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. All rights reserved. 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. On affected devices FDA has identified this as a first step, your! Not be excluded under the Australian and new Zealand Consumer Law Australian and new Zealand Consumer Law appropriate next.... 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