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. Please note that the information available at these links has not been separately verified by Philips Australia. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. The products were designed according to, and in compliance with, appropriate standards upon release. Should affected devices be removed from service? These printed instructions include a QR code you can scan, which will take you to an online instructional video. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model. These printed instructions include a QR code you can scan, which will take you to an online instructional video. Images may vary. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 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. 1. 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. No further products are affected by this issue. What happens after I register my device, and what do I do with my old device? Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. 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. When will the correction for this issue begin? To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Particles or other visible issues? The application for discontinuance will be heard by the Federal Court on 3 April 2023. Is this a recall? 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. 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. Is there a question we can answer for you? You are about to visit a Philips global content page. No further products are affected by this issue. Replace these devices with an unaffected device. Overview. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series). Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. The recall includes many mechanical ventilator . We know how important it is to feel confident that your therapy device is safe to use. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. We thank you for your patience as we work to restore your trust. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. Additional Resources: Medical Device Recall. Register your device on the Philips recall website or call 1-877-907-7508. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. 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. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Please read the Notice carefully. 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. 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. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. ~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. We are in touch with relevant customers and patients. Please note that some people will also receive a copy of the Notice by email or post. To date there have been no reports of death from exposure to the recalled devices. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. However, this new recall does apply to some of the devices recalled . If you have a secondary back up device, switch over to that device. The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. The potential risks associated with this recall include: If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. Updating everyone on what they need to know and do, and to participate in the corrective action. The new material will also replace the current sound abatement foam in future products. 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. Philips Australia will work with your clinical care team to arrange a loan device, where required. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Doing this could affect the prescribed therapy. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. Go to www.philips.com/src-update and click on "Begin registration process" (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process") Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas) Koninklijke Philips N.V., 2004 - 2023. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. Philips Respironics Product Recall: Important Information for AvantSleep Clients. Register your device (s) on Philips' recall website . 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. CHEST Issues Joint Statement in Response to Philips Device Recall . Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. What devices have you already begun to repair/replace? Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 2. Contact your clinical care team to determine if a loan device is required. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips has been in full compliance with relevant standards upon product commercialization. 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. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. 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. What is the advice for patients and customers? The return shipment for your old device is pre-paid so there is no charge to you. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 3. 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. For more information click here. Consult with your physician to determine the benefits of continuing therapy and potential risks. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. You are about to visit the Philips USA website. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Discuss the best treatment course with the patient. This factor does not refer to heat and humidity generated by the device for patient use. 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. The products were designed according to, and in compliance with, appropriate standards upon release. Can I trust the new foam? Are you still taking new orders for affected products? This could affect the prescribed therapy. For more information about your replacement device including video instructions click here. 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. [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. ) / field safety notice for the global sleep and respiratory Markets your physician to discuss whether it is feel. Official Royal Philips Healthcare ( `` Philips '' ) website the Federal Court on 3 April 2023 replacement your... Make an appointment with your clinical care team to determine appropriate next steps particles are detected the. Next steps thank you for your patience as we work to restore your.. A comprehensive correction program to support patients with an affected device replace the current sound foam! 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