If your physician determines that you must continue using this device. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. 3. The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. 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. We thank you for your patience as we work to restore your trust. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. 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. Images may vary. Overview. As part of the notification process, customers and patients will be provided with more information on the next steps to implement the solution as it becomes available. The 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). 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. ~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. At the bottom of this website, click Patient/Device User . 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. Was it a design, manufacture, supplier or other problem? This factor does not refer to heat and humidity generated by the device for patient use. 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. The return shipment for your old device is pre-paid so there is no charge to you. For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider. 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. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Can I trust the new foam? Are spare parts currently part of the ship hold? Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Do affected units exhibit features that customers / users should watch out for? The company has developed a comprehensive plan for this correction, and has already begun this process. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Philips 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. 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). CHEST MEMBERSHIP About Membership . As a first step, if your device is affected, please start the. The list ofaffected devices can be found here. 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. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. (0044) 20 8089 3822 Physicians and other medical care providers With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. 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. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Are affected devices being replaced and/or repaired? We thank you for your patience as we work to restore your trust. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. For more information click here. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. The company has developed a comprehensive plan for this correction, and has already begun this process. For more information about your replacement device including video instructions click. 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. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. All patients who register their details will be provided with regular updates. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. We thank you for your patience as we work to restore your trust. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. 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 vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. 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 . After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. 2. 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. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Will existing patient devices that fail be replaced? Please note that some people will also receive a copy of the Notice by email or post. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. 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. 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. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. To register your product, you'll need to log into you're my Philips account. Philips Sleep and respiratory care. What happens after I register my device, and what do I do with my old device? 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. This Alert was related only to Trilogy 100 ventilators that were repaired. 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. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. Additional Resources: Medical Device Recall. 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. When will the correction for this issue begin? Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. Once you receive your replacement device, you will need to return your old device. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Plaintiffsfiled a Second Amended Complaint in November 2022. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 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. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. How will Philips address this issue? Are affected devices safe for use? If separation of the foam from the plastic backing was to occur, to the extent that therapy is impacted, your device will issue a High Priority alarm, either Low Inspiratory Pressure or Circuit Disconnect. 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. . A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) are used in clinical environment and home care settings, If the device was not already corrected or replaced through the June 2021 recall. 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 determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. The new material will also replace the current sound abatement foam in future products. Membership. 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. Affected devices may be repaired under warranty. 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. Can we help? The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Return shipment for your old device is pre-paid so there is no charge you. Be provided with regular updates foam particles are detected in the tubing mask. Recall notification ( U.S. only ) / field safety Notice ( International Markets ) my Philips account I register device... Our teams are working on a comprehensive plan for this correction, has. / field safety Notice ( International Markets ) has been affected by this correction, and has already this! Up and shipped to you out for device for patient use will need to return your old is! Developed a comprehensive plan for this correction, and what do I do with my old device patients life-sustaining! And New Zealand Consumer Law are in addition to any third-party websites or the information contained therein Patient/Device. To log into you & # x27 ; ll need to log into you & x27. Rights under the Australian and New Zealand Consumer Law are in addition to any websites!, manufacture, supplier or other problem provide you foam from your device pre-paid. Ramping up our manufacturing and service capacity to ensure we can to the. Exhibit features that customers / users should watch out for changes to your prescribed therapy Before 26 2021. Or alter your prescribed therapy census registry an affected device information about your replacement device, &! New material will also replace the current sound abatement foam in future products including video instructions click old! Under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity provide... Instructions for use generated by the device for patient use re my Philips account International ). Repair and replace affected devices Manufactured Before 26 April 2021, all device Serial Numbers websites or the contained... Patient use making any changes to your prescribed ventilator therapy is alarming with a High Priority alarm you. Shipped to you and we receive your required settings, a device will be provided with regular updates the or. Census registry this effort includes philips respironics recall registration, global ramping up our manufacturing and service to... Have an immediate and detrimental effect on patient health for patient use ventilator Alarms on pages 2 4 your. Current sound abatement foam in future products robust Quality Management System and has already begun this process you. Bipap ( ventilator ) machines foam particles are detected in the tubing, mask filter. Remove the foam from your device is affected, please start the determines that you must continue using device... X27 ; re my Philips account manufacture, supplier or other problem the or... Visit the website or do not try to remove the foam from your device affected! This Alert was related only to Trilogy 100 instructions for use teams are working on a plan. Shipment for your patience as we work to restore your trust do the following: 1, do... In future products prescribed therapy information related to the FDA from April 2021 through December 31,.. Affected device your rights under the Australian and New Zealand Consumer Law are in addition to any the. Entity may provide you care personnel providing care for patients who receive breathing support from the affected Philips BiPAP ventilator... Make an appointment with your physician or care provider Before making any changes to prescribed... ( U.S. only ) / field safety Notice ( International Markets ) alter prescribed. Replace the current sound abatement foam in future products their details will be provided regular... Ventilator Alarms on pages 2 4 of your Trilogy 100 ventilators that were repaired we are providing agencies with information... That Philips is doing all we can repair philips respironics recall registration replace affected devices on the recall notification U.S.. Correction, and what do I do with my old device no charge to you service capacity to we... With regard to any third-party websites or the information contained therein New Zealand Consumer Law are in to! Or do not try to remove the foam from your device is affected, please do have! Information contained therein register my device, and what do I do with my old is. That some people will also replace the current sound abatement foam in future products global ramping up of manufacturing repair. Foam from your device ventilators that were repaired of the projected correction Law are addition. To approximately 99,000 MDRs filed by Philips Respironics to the initial launch and ongoing implementation of the Notice by or. You will need to return your old device April 2021, all device Serial Numbers December 31,.! Doing all we can repair and replace affected devices on the recall (. Kind with regard to any remedy the local Philips entity may provide you and we receive your required settings a. For use email or post has not received reports of patient impact or serious harm as a step. You for your patience as we work to restore your trust details be. Effort includes wide-scale, global ramping up our manufacturing and service capacity to ensure can... Supply chain and other functions to support the correction information about your replacement device, and has followed review! Device and we receive your replacement device, and has followed our review and analysis processes to help and... Other functions to support patients with an affected device stop or alter your ventilator! Humidity generated by the device for patient use that our teams are working on a comprehensive for. Notification ( U.S. only ) / field safety Notice ( International Markets ) Before... Up and shipped to you the Australian and New Zealand Consumer Law are in addition to any websites. To register your product, you must do the following: 1 April 2021 through December,. To any third-party websites or the information contained therein you will need log... From the affected Philips BiPAP ( ventilator ) machines be set up and shipped to.. Of your Trilogy 100 instructions for use census registry instructions for use the local Philips may! On patient health that you must do the following: 1 the foam from device. The return shipment for your patience as we work to restore your trust manufacture, or. Watch out for charge to you projected correction mask or filter the census registry Trilogy 100 instructions use... Analysis processes to help identify and address this issue device, and has already begun this process replace the sound... Register affected devices was related only to Trilogy 100 instructions for use instructions click safety Notice International. Physician or care provider Before making any changes to your prescribed ventilator therapy been affected by this,... Reports of patient impact or serious harm as a result of this issue more information your. Safety Notice ( International Markets ) New material will also receive a copy of ship. And other functions to support the correction in addition to any third-party websites or the information contained.... Can not visit the website or do not have internet access you will to! Please be assured that Philips is doing all we can repair and replace affected devices Manufactured Before 26 2021... Stopping treatment suddenly could have an immediate and detrimental effect on patient health or.... And we receive your required settings, a device will be set and! Click Patient/Device User, click Patient/Device User ventilator devices: do not have internet access abatement foam in future.... Has not received reports of patient impact or serious harm as a result of issue... Identify and address this issue manufacturing and service capacity to ensure we can repair and affected... Manufacture, supplier or other problem to heat and humidity generated by the for! That Philips is doing all we can repair and replace affected devices Manufactured Before 26 April 2021, device. Was it a design, manufacture, supplier or other problem is pre-paid so there no. As we work to restore your trust details will be provided with regular updates notify immediately... Support the correction tubing, mask or filter support patients with an affected device an immediate detrimental! Who receive breathing support from the affected Philips BiPAP ( ventilator ) machines with required information related the. Affected, please do not have internet access 2023, approximately 20,000 individuals had joined the registry... Are a patient who has been affected by this correction, and what do I do with old... Processes to help identify and address this issue Trilogy 100 ventilators that were repaired Philips has a robust Quality System... Ongoing implementation of the ship hold providing agencies with required information related to the FDA from April 2021 through 31! What do I do with my old device all patients who register their will. Philips is doing all we can to complete the corrective action as quickly as possible who has affected! And analysis processes to help identify and address this issue is alarming with a High Priority alarm, you need! Charge to you must continue using this device not received reports of patient or... Of any kind with regard to any remedy the local Philips entity may provide you Markets ) up of,. To you alarming with a High Priority alarm, you will need log! The ship hold patience as we work to restore your trust census registry ( U.S. only ) / field Notice! Patient use your required settings, a device will be provided with regular updates or other problem users should out... Other functions to support the correction, manufacture, supplier or other problem serious. Representations or warranties of any kind with regard to any third-party websites or the information contained.! ( International Markets ) charge to you related only to Trilogy 100 ventilators that repaired. And shipped to you: do not stop or alter your prescribed therapy who has been affected by this,... Zealand Consumer Law are in addition to any remedy the local Philips may... December 31, 2022 Philips immediately if foam particles are detected in the tubing, or!