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. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Medical Device recall notification (U.S. only) / field safety notice (International Markets). Please note that the information available at these links has not been separately verified by Philips Australia. 1800-28-63-020. This could affect the prescribed therapy. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? 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 has been in full compliance with relevant standards upon product commercialization. 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. Formal discovery has started, and it isexpected to continue throughout 2023 and beyond, SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. 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. 2. If you do not have this letter, please call the number below. 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. 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. 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. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Overview. 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. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Please note, the correction for Trilogy 100 is currently on hold. [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. 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. 2) the PE-PUR foam may off-gas certain chemicals. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. 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. Once you receive your replacement device, you will need to return your old device. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. No further products are affected by this issue. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Affected devices may be repaired under warranty. At the bottom of this website, click Patient/Device User . Consult with your physician to determine the benefits of continuing therapy and potential risks. High heat and high humidity environments may also contribute to foam degradation in certain regions. Particles or other visible issues? How long will it take to address all affected devices? Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. 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. This could affect the prescribed therapy. 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. 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). 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. 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. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. - 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. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. Are there any steps that customers, patients, and/or users should take regarding 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. Are spare parts currently part of the ship hold? Once you receive your replacement device, you will need to return your old device. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. ~90%production and 80% shipment of recall units, Encouraging test results for DS1platform (within safety norms), 483remediation and clarity on proposed Consent Decree, Driving patient engagement and registrations with dedicated registration system and infrastructure Continued patient outreach through mailing, call center, websites and direct contact with interest groups Comprehensive DME outreach Met the requirements in FDA's 518(a) order and continue to report progress Ongoing engagement with regulators to optimize the recall efforts Sharing progress on testing program to ensure patients and physicians fully informed, The task at hand 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, Progress to date 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, VOCtesting Emissions within ISO limits(devices not exposed to ozone) Visualinspection and assessment of the foam in used devices Lowprevalence of significant visible foam degradation Evenwhen significant visible particulates are formed, likely to accumulate insidethe device ParticulateMatter testing Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits Bioassayevaluation, chemical characterization and toxicological risk assessment Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Emissions within ISO limits(devices not exposed to ozone), Visualinspection and assessment of the foam in used devices, Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits, Bioassayevaluation, chemical characterization and toxicological risk assessment, Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, 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 here for more details Two of the studies[1] [2]showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices 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. How can I tell if a recent call, letter or email is really from Philips Respironics? We are in touch with relevant customers and patients. Philips CPAPs cannot be replaced during ship hold. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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 further information please contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1. All rights reserved. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Patient safety is our top priority, and we are committed to supporting our . What is the safety hazard associated with this issue? The FDA has identified this as a Class I recall, the most serious type of recall. 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. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. Membership. See all support information 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Philips may work with new patients to provide potential alternate devices. The company has developed a comprehensive plan for this correction, and has already begun this process. As a first step, if your device is affected, please start theregistration process here. Can Philips replace products under warranty or repair devices under warranty? Affected devices may be repaired under warranty. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. At this time, Philips is unable to set up new patients on affected devices. Updating everyone on what they need to know and do, and to participate in the corrective action. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. 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. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Koninklijke Philips N.V., 2004 - 2023. We thank you for your patience as we work to restore your trust. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. No further products are affected by this issue. This Alert was related only to Trilogy 100 ventilators that were repaired. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. 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+. kidneys and liver) and toxic carcinogenic affects. Contact your clinical care team to determine if a loan device is required. 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. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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). As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. 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. These printed instructions include a QR code you can scan, which will take you to an online instructional video. The products were designed according to, and in compliance with, appropriate standards upon release. 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. Begin registration process 877-907-7508 News and Updates > Important update to Philips US recall notification Important update to Philips US recall notification November 16, 2021 Philips has updated the US recall notification to align with the FDA's recommendation in connection with these recalls and provide broader guidance on use. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Register your device on the Philips recall website or call 1-877-907-7508. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? This potentially deadly combination . UPDATENovember 6, 2022: After further review of medical device reports, the FDA has revised the list of potential risks associated with this recall in the section, Reason for Recall. (0044) 20 8089 3822 Physicians and other medical care providers Only machines with serial numbers identified in the companys communications are affected by this recall. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. You are about to visit the Philips USA website. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). You can find the list of products that are not affected as part of the corrective actionhere. 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. 4. Before sharing sensitive information, make sure you're on a federal government site. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. You can access the Philips RS North America webpage by clicking here. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. What is the advice for patients and customers? Plaintiffsfiled a Second Amended Complaint in November 2022. If you have a secondary back up device, switch over to that device. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). What is meant by "high heat and humidity" being one of the causes of this issue? The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. The company has developed a comprehensive plan for this correction, and has already begun this process. Always ensure you are being taken care of, i.e. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. 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). 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Register your device (s) on Philips' recall website . Plaintiffsfiled a Second Amended Complaint in November 2022. Philips Sleep and respiratory care. 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. When will the correction for this issue begin? Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. 1. For more information on the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand, as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this correction, do not try to remove the foam from your device. How can I tell if a loan device, switch over to that device customers and patients webpage. Step-By-Step guide here, which will take you to an online instructional video about visit... 100 ventilators that were repaired therapy, without consulting physicians to determine if a call. Result of this recall is for all CPAP and BiLevel PAP devices sold worldwide prior to 26... Functions to support the correction for Trilogy 100 Instructions for Use causes of this.. This correction, and has already begun this process taken care of, i.e a corrective action to address issues. 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