We thank you for your patience as we work to restore your trust. Are customers entitled to warranty replacement, repair, service or other mitigations? At this time, affected devices are on manufacturing and ship hold. (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. Please note that some people will also receive a copy of the Notice by email or post. The relevant subsidiaries are cooperating with the agency. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. This information has not been separately verified by Philips Electronics Australia Ltd. Replace these devices with an unaffected device. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 2) the PE-PUR foam may off-gas certain chemicals. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. How long will it take to address all affected devices? For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 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: For patients using life-sustaining mechanical ventilator devices: The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. This potentially deadly combination . 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 . Process 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 anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. You can register here. You are about to visit the Philips USA website. The issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration. At the bottom of this website, click Patient/Device User . Images may vary. 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. You are about to visit the Philips USA website. 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. See all support information 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. On June 14th, 2021, Philips Respironics released a safety communication statement that they will be issuing a device recall for almost all of their machines sold from 2009 to the present day. The relevant subsidiaries are cooperating with the agency. 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. 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. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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. Koninklijke Philips N.V., 2004 - 2023. The products were designed according to, and in compliance with, appropriate standards upon release. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. At the bottom of the page, select "I am a Patient/Device User/Caregiver". We are in touch with relevant customers and patients. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, was corrected or replaced through the June 2021 recall, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, report adverse reactions or quality problems, Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+. Call us at +1-877-907-7508 to add your email. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. 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. Only machines with serial numbers identified in the companys communications are affected by this recall. At this time, Philips is unable to set up new patients on affected devices. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Affected devices may be repaired under warranty. If you do not have this letter, please call the number below. 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 Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. Philips may work with new patients to provide potential alternate devices. 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. The letter offered the following recommendations. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Do affected units exhibit features that customers / users should watch out for? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. The FDA has identified this as a Class I recall, the most serious type of recall. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. We thank you for your patience as we work to restore your trust. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) DreamStation Go With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Register your device at the Phillips Respironics website (link below). After registration, we will notify you with additonal information as it becomes available. Philips has been in full compliance with relevant standards upon product commercialization. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and corrected devices is a silicone foam. 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. Overview. 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. The return shipment for your old device is pre-paid so there is no charge to you. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. Create account Create an account The device types are: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) 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. 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). Why did Philips issue the global recall notification in June 2021? Do not stop or alter your prescribed ventilator therapy. Philips CPAPs cannot be replaced during ship hold. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Additionally, the device Instructions for Use provide product identification information to assist with this activity. The products were designed according to, and in compliance with, appropriate standards upon release. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. Talk with health care providers to decide if your care and treatment should change as a result of this recall. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. 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. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). 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 your physician determines that you must continue using this device, use an inline bacterial filter. 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. 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. All patients who register their details will be provided with regular updates. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use. In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. Patients who are concerned should check to see if their device is affected by the corrective action. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. 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. 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. What happens after I register my device, and what do I do with my old device? June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen; Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Can I trust the new foam? 2. Click the link below to begin our registration process. This Alert was related only to Trilogy 100 ventilators that were repaired. At this time, Philips is unable to set up new patients on affected devices. 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. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Philips Quality Management System has been updated to reflect these new requirements. Can we help? 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 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. This could affect the prescribed therapy. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. Philips may work with new patients to provide potential alternate devices. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. 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. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. Philips is notifying regulatory agencies in the regions and countries where affected products are available. 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. Have regulatory authorities classified the severity of the recall? Has Philips received any reports of patient harm due to this issue? 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. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. 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. However, this new recall does apply to some of the devices recalled . 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. Can Philips replace products under warranty or repair devices under warranty? In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. 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 on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. What is the safety hazard associated with this issue? 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. Consult with your physician as soon as possible to determine appropriate next steps. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. 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. Discuss the best treatment course with the patient. Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Plaintiffsfiled a Second Amended Complaint in November 2022. 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