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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Replace these devices with an unaffected device. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. How are you removing the old foam safely? 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. Is this a recall? 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. The recall includes many mechanical ventilator . Selected products However, this new recall does apply to some of the devices recalled in June 2021. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. 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. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. 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). * Voluntary recall notification in the US/field safety notice for the rest of the world. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. This Alert was related only to Trilogy 100 ventilators that were repaired. Why did Philips issue the global recall notification in June 2021? The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. 4. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. 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. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. If you have a secondary back up device, switch over to that device. Please note that the information available at these links has not been separately verified by Philips Australia. 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. For more information click here. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. 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 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. 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. 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. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. All rights reserved. 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. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US The affected products are identified in the tables below: A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. 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. For more information about your replacement device including video instructions click here. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 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. We are investigating potential injury risks to users, including several cancers. We are in touch with relevant customers and patients. 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). CHEST Issues Joint Statement in Response to Philips Device Recall . Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio. The relevant subsidiaries are cooperating with the agency. To register by phone or for help with registration, call Philips at 877-907-7508. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. 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). For more information on the recall notification for customers, users and physicians, please click here. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. 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. Philips will be moving to dismiss theSecond Amended Complaint, Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters, Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues, These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers, The FDA acknowledges that the submission of an. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. This information has not been separately verified by Philips Electronics Australia Ltd. The products were designed according to, and in compliance with, appropriate standards upon release. 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. This could affect the prescribed therapy. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. What is meant by "high heat and humidity" being one of the causes of this issue? This recall notification / field safety notice has not yet been classified by regulatory agencies. No further products are affected by this issue. Do not stop or alter your prescribed ventilator therapy. Click the link below to begin our registration process. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Click "Next". How it works. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Updating everyone on what they need to know and do, and to participate in the corrective action. The new material will also replace the current sound abatement foam in future products. All rights reserved. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. Membership. [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. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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