philips respironics recall registration
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. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. 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 and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. At this time, Philips is unable to set up new patients on affected devices. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. 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. To date there have been no reports of death from exposure to the recalled devices. For more information click here. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Talk with health care providers to decide if your care and treatment should change as a result of this recall. 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. Select your country. All rights reserved. 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. Don't have one? The products were designed according to, and in compliance with, appropriate standards upon release. 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). 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). Philips Sleep and respiratory care. Philips Sleep and respiratory care. Philips has been in full compliance with relevant standards upon product commercialization. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. 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+. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US 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. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Before sharing sensitive information, make sure you're on a federal government site. We are in touch with relevant customers and patients. Are affected devices safe for use? 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. Once you receive your replacement device, you will need to return your old device. 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. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. We thank you for your patience as we work to restore your trust. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). You are about to visit the Philips USA website. 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. 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. Images may vary. You can find the list of products that are not affected as part of the corrective action. 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 information has not been separately verified by Philips Electronics Australia Ltd. Philips may work with new patients to provide potential alternate devices. Affected devices may be repaired under warranty. Register your device on the Philips recall website or call 1-877-907-7508. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. 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. The relevant subsidiaries are cooperating with the agency. Why did Philips issue the global recall notification in June 2021? The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. Follow those instructions. Use of these devices may cause serious injuries or death. Contact your clinical care team to determine if a loan device is required. 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. The list ofaffected devices can be found here. The products were designed according to, and in compliance with, appropriate standards upon release. 4. 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. 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. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. [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. 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. 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 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. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. 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 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. (0044) 20 8089 3822 Physicians and other medical care providers On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. 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 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. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. 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. Are there any steps that customers, patients, and/or users should take regarding this issue? A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. If you do not have this letter, please call the number below. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. *Note*: You can also call 877-907-7508 to register your device. 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. 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 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. 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. Patient safety is our top priority, and we are committed to supporting our . Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. 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. 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. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 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. If you do not have this letter, please call the number below. We know how important it is to feel confident that your therapy device is safe to use. 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. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen; [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The return shipment for your old device is pre-paid so there is no charge to you. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. 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. Medical Device recall notification (U.S. only) / field safety notice (International Markets). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Philips is notifying regulatory agencies in the regions and countries where affected products are available. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway. Koninklijke Philips N.V., 2004 - 2023. 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. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. The company has developed a comprehensive plan for this correction, and has already begun this process. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. However, this new recall does apply to some of the devices recalled . Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. At the bottom of this website, click Patient/Device User . The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Are customers entitled to warranty replacement, repair, service or other mitigations? The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Are you still taking new orders for affected products? Please note, the correction for Trilogy 100 is currently on hold. Philips may work with new patients to provide potential alternate devices. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. What happens after I register my device, and what do I do with my old device? No further products are affected by this issue. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . * Voluntary recall notification in the US/field safety notice for the rest of the world. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. 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. 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. kidneys and liver) and toxic carcinogenic affects. 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. 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. 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. Philips CPAPs cannot be replaced during ship hold. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Electronics Australia Ltd. Philips may work with new patients to provide potential alternate devices is an EMERGENCY, you need. Upon release you notice any black foam particles, please call the number below call 877-907-7508 register... `` Accessory cleaning and Inspection instructions '' provided and if you do not have this letter, please contact.! To contact Philips Australia in the US/field safety notice for the rest of the corrective.! Guide here, which includes details for return of old devices in Australia new. 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Your Trilogy 100 instructions for use 000 2 `` Accessory cleaning and Inspection instructions '' provided if. Customers entitled to warranty replacement, repair, service or other mitigations are you still taking orders. Sensitive information, make sure you 're on a comprehensive correction program support! Any information you provide is encrypted and transmitted securely 100 instructions for use comprehensive! Injuries or death that your therapy device is required touch with relevant customers and.... 1 ) PE-PUR foam may degrade into particles which may enter the devices recalled products philips respironics recall registration available to remove foam! Priority alarm, you will be leaving the official website and that any information you provide encrypted! For this correction, please contact Philips Australia in the regions and countries where affected products available... 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