Philips Sleep and respiratory care. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. You are about to visit the Philips USA website. If you have a secondary back up device, switch over to that device. We know how important it is to feel confident that your therapy device is safe to use. 1800-28-63-020. This potentially deadly combination . See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. December 2, 2021 (latest update) . Philips has been in full compliance with relevant standards upon product commercialization. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips is notifying regulatory agencies in the regions and countries where affected products are available. Click the link below to begin our registration process. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Always ensure you are being taken care of, i.e. 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. Patients who are concerned should check to see if their device is affected by the corrective action. 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. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. The relevant subsidiaries are cooperating with the agency. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). Do not stop or alter your prescribed ventilator therapy. This Alert was related only to Trilogy 100 ventilators that were repaired. Click the link below to begin our registration process. 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. 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. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. 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. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. Do affected units exhibit features that customers / users should watch out for? Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Please note that some people will also receive a copy of the Notice by email or post. How it works. 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). For more information about your replacement device including video instructions click. 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. - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. 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. Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. What devices have you already begun to repair/replace? Philips may work with new patients to provide potential alternate devices. 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. Doing this could affect the prescribed therapy. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Philips Quality Management System has been updated to reflect these new requirements. 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. Medical Device recall notification (U.S. only) / field safety notice (International Markets). 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. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. At this time, affected devices are on manufacturing and ship hold. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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. Register your device at the Phillips Respironics website (link below). At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 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. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 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. Follow the steps for registering your device. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. At the bottom of this website, click Patient/Device User . We thank you for your patience as we work to restore your trust. 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. 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. 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. 4. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air 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. 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. 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). 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. Where do I direct questions about my replacement device? The new material will also replace the current sound abatement foam in future products. If your physician determines that you must continue using this device, use an inline bacterial filter. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. The relevant subsidiaries are cooperating with the agency. 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. 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. 4. Additional Resources: Medical Device Recall. You are about to visit the Philips USA website. 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. Koninklijke Philips N.V., 2004 - 2023. You are about to visit a Philips global content page. The site is secure. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. To register your product, you'll need to log into you're my Philips account. The plastic may also cause the machine to fail and stop working suddenly during use. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a claim if their unit is affected. Once you receive your replacement device, you will need to return your old device. Koninklijke Philips N.V., 2004 - 2023. Follow those instructions. The return shipment for your old device is pre-paid so there is no charge to you. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click, Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations, Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis, In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. Are customers entitled to warranty replacement, repair, service or other mitigations? Affected devices may be repaired under warranty. 1. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. You are about to visit a Philips global content page. This recall notification / field safety notice has not yet been classified by regulatory agencies. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. At this time, Philips is unable to set up new patients on affected devices. Is this a recall? Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Are spare parts currently part of the ship hold? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Register your product and enjoy the benefits. To resolve this situation as quickly as we can, we are doing the following: 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. Have regulatory authorities classified the severity of the recall? 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. https://doi.org/10.1183/13993003.00551-2022, Continued patient outreach through mailing, call center, websites and direct contact with interest groups, Met the requirements in FDA's 518(a) order and continue to report progress, Around 5.5M devices expected to berepaired or replaced, Equivalent to over 5x previous annualproduction volume, >1 thousand new product configurationsreleased globally, Partnering with DMEs for patientdelivery, Quadrupledproduction capacity compared to pre-recall, >1,000people cross functional team engaged, Dependencyon supply of materials and global logistics capacity, ~90% production and 80% shipment of recall units in 2022, Lowprevalence of significant visible foam degradation, Evenwhen significant visible particulates are formed, likely to accumulate insidethe device, Finalizetoxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in DreamStation1 devices Expected in Q2 2023, Completetesting for SystemOne(~26% of registered devices) and DreamStationGo (~1%), which contain the exact same foam as the DreamStation1 devices Expected in Q2 2023, CompleteVOC and PM testing, as well as chemical evaluation and toxicologicalassessments for Trilogy 100/200 (~3%) and OmniLab(~2%), where a different PE-PUR foam is used Expected in Q3 2023, Ongoingengagement with FDA and other competent authorities, There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click, Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices, The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. 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. We thank you for your patience as we work to restore your trust. 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. 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. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. 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. 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. If you have not done so already, please click here to begin the device registration process. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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 CPAP Recall Information. 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. (, 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.