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 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. How will Philips address this issue? However, this new recall does apply to some of the devices recalled . 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. All rights reserved. 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. You are about to visit the Philips USA website. The new material will also replace the current sound abatement foam in future products. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. We thank you for your patience as we work to restore your trust. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. 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). 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 list of, If their device is affected, they should start the. Click the link below to begin our registration process. 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. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Are affected devices safe for use? 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 . 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. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. 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. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. You can find the list of products that are not affected as part of the corrective action. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. High heat and high humidity environments may also contribute to foam degradation in certain regions. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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). Membership. Are affected devices continuing to be manufactured and/or shipped? The company has developed a comprehensive plan for this correction, and has already begun this process. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. 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. It includes further information such as what steps are available to Group Members in the class action. Once you receive your replacement device, you will need to return your old device. Philips may work with new patients to provide potential alternate devices. Can I trust the new foam? A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. You are about to visit the Philips USA website. However, this new recall does apply to some of the devices recalled in June 2021. 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. 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. 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 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. 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. 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. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. For more information about your replacement device including video instructions click. We are in touch with relevant customers and patients. 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. Register your device at the Phillips Respironics website (link below). Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Membership & Community. [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. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. Call us at +1-877-907-7508 to add your email. Has Philips received any reports of patient harm due to this issue? 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Process Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers The FDA acknowledges that the submission of anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. You are about to visit a Philips global content page. 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 makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? 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. Are customers entitled to warranty replacement, repair, service or other mitigations? The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. No further products are affected by 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. The products were designed according to, and in compliance with, appropriate standards upon release. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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). 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. This potentially deadly combination . In the event of exposure to degraded foam: 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. The return shipment for your old device is pre-paid so there is no charge to you. Please read the Notice carefully. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). Philips has been in full compliance with relevant standards upon product commercialization. This could affect the prescribed therapy. Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. 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. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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. 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. 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. 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. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? Please note that the information available at these links has not been separately verified by Philips Australia. Please note that some people will also receive a copy of the Notice by email or post. 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. 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 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: 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). When will the correction for this issue begin? Register your product and enjoy the benefits. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Can Philips replace products under warranty or repair devices under warranty? This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. If you do not have this letter, please call the number below. Philips Quality Management System has been updated to reflect these new requirements. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. For more information on the recall notification for customers, users and physicians, please click here. 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. Always ensure you are being taken care of, i.e. CHEST MEMBERSHIP About Membership . We know how important it is to feel confident that your therapy device is safe to use. Before sharing sensitive information, make sure you're on a federal government site. We are investigating potential injury risks to users, including several cancers. 1800-28-63-020. Particles or other visible issues? 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. Koninklijke Philips N.V., 2004 - 2023. 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. 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. . (0044) 20 8089 3822 Physicians and other medical care providers Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. Koninklijke Philips N.V., 2004 - 2023. How did this happen, and what is Philips doing to ensure it will not happen again? Additionally, the device Instructions for Use provide product identification information to assist with this activity. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Consult your Instructions for Use for guidance on installation. The following updates in relation to device testing have been released by Philips RS North America on this webpage: Please note that the Philips RS North America website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. 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. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. CHEST Issues Joint Statement in Response to Philips Device Recall . See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. The relevant subsidiaries are cooperating with the agency. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) DreamStation Go With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. *Note*: You can also call 877-907-7508 to register your device. We thank you for your patience as we work to restore your trust. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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 foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. Is Philips certain that this issue is limited to the listed devices? No further products are affected by this issue. 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. 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. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. Replace these devices with an unaffected device. As a first step, if your device is affected, please start the. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. An official website of the United States government, : Register your device on the Philips recall website or call 1-877-907-7508. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. You can find the list of products that are not affected as part of the corrective actionhere. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. For more information click here. What is the advice for patients and customers? Updating everyone on what they need to know and do, and to participate in the corrective action. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. The .gov means its official.Federal government websites often end in .gov or .mil. Philips has been in full compliance with relevant standards upon product commercialization. If you have not done so already, please click here to begin the device registration process. 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. Can we help? Theremediation of this field safety notice is underway and has started for the following devices: Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. 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 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. Updating everyone on what they need to know and do, and to participate in the corrective action. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Testing is ongoing and you can obtain further information about the. Philips CPAPs cannot be replaced during ship hold. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. For more information about your replacement device including video instructions click here. 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. How are you removing the old foam safely? 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.