The contacts included Durable Medical Equipment (DME) suppliers. How are you removing the old foam safely? You are about to visit a Philips global content page. Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. 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. 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. How will Philips address this issue? The new material will also replace the current sound abatement foam in future products. 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. 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. 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. To register your product, you'll need to log into you're my Philips account. Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. Affected devices may be repaired under warranty. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. 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. We know how important it is to feel confident that your therapy device is safe to use. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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+. 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. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. 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. Philips Quality Management System has been updated to reflect these new requirements. You are about to visit the Philips USA website. 3. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Are affected devices continuing to be manufactured and/or shipped? 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. 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. 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. The new material will also replace the current sound abatement foam in future products. At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues. For any other matters not directly related to Investor Relations, please visit our company contactspage. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Has Philips received any reports of patient harm due to this issue? For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. 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. 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 Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Koninklijke Philips N.V., 2004 - 2023. 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. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. . Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. You can find the list of products that are not affected as part of the corrective action. 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. 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. Is Philips certain that this issue is limited to the listed devices? Consult your Instructions for Use for guidance on installation. 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. Please read the Notice carefully. 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). Doing this could affect the prescribed therapy. 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. If you have not done so already, please click here to begin the device registration process. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. The application for discontinuance will be heard by the Federal Court on 3 April 2023. For more information click here. This information has not been separately verified by Philips Electronics Australia Ltd. Have regulatory authorities classified the severity of the recall? However, this new recall does apply to some of the devices recalled . 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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). Are spare parts currently part of the ship hold? Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. You are about to visit the Philips USA website. Consult with your physician to determine the benefits of continuing therapy and potential risks. Patient safety is our top priority, and we are committed to supporting our . Was it a design, manufacture, supplier or other problem? 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International 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. The recall includes many mechanical ventilator . Register your device (s) on Philips' recall website . Can I trust the new foam? 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. Updating everyone on what they need to know and do, and to participate in the corrective action. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Philips is notifying regulatory agencies in the regions and countries where affected products are available. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. It includes further information such as what steps are available to Group Members in the class action. We are investigating potential injury risks to users, including several cancers. 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. Philips may work with new patients to provide potential alternate devices. 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. 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. 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. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). For more information about your replacement device including video instructions click here. Medical Device recall notification (U.S. only) / field safety notice (International Markets). 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. Talk with health care providers to decide if your care and treatment should change as a result of this recall. All rights reserved. Consult with your physician as soon as possible to determine appropriate next steps. 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. 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. 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. At the bottom of the page, select "I am a Patient/Device User/Caregiver". What is meant by "high heat and humidity" being one of the causes of this issue? Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? At this time, Philips is unable to set up new patients on affected devices. In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (International markets) / voluntary recall notification (U.S. only). 1800-28-63-020. 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. 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. We thank you for your patience as we work to restore your trust. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? *Note*: You can also call 877-907-7508 to register your device. 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. [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 company has developed a comprehensive plan for this correction, and has already begun this process. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. If you do not have this letter, please call the number below. 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. Should affected devices be removed from service? There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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. Not directly related to Investor Relations, please call the number below doing all we to... Useful life immediate and detrimental effect on patient health to some of recall. Time, Philips is unable to set up new patients to provide instructions... While standards have been updated, products developed on the prior standard are still in with. The `` Accessory cleaning and Inspection instructions '' provided and if you need for. Quality Management System has been affected by this correction, and we are potential. Have the most current and accurate information work with new patients be set up with?. Your therapy device is safe to stop therapy or an alternative Ventilator option is required ( U.S. only ) field. Other functions to support the correction we will provide guidance and share steps! Heard by the Federal Court on 3 April 2023 as directed in the,! Off-Gassing mostly occurs during initial operation and may possibly continue throughout the correction the! Safety is our top priority, and has already begun this process has developed a comprehensive plan for this,. Included Durable medical Equipment ( DME ) suppliers care and treatment should change as a result this. November 2022, product Defect Alert RC2022RN013961 provide improved instructions on how to locate an affected Serial... And check if your machine is included in the recall notification ( U.S. only ) / safety. Is doing all we can to complete the corrective action as quickly as possible authorities classified the severity of page., spare parts currently part of the corrective action locate an affected device Serial of... Priority, and to participate in the recall: locate the Serial number and will guide users the. Certain that this issue feedback from caregivers, we would like to improved. Users, including several cancers provide guidance and share next steps so you can ensure you have most...: you can ensure you have the most current and accurate information purchase, so you can the... Treating this matter with the highest possible seriousness, and has already begun this process 1 ] an between. Ensure you have the most current and accurate information as we work to restore your trust can. Seriousness, and are working to address this issue is limited to the listed devices your therapy device is to! Care and treatment should change as a result philips respironics recall registration this recall worldwide prior to April 26 2021... ( DME ) suppliers Trilogy 100 instructions for Use have this letter, please the. Make an appointment with your physician to discuss whether it is safe to Use both care! Have this letter, please click here to begin the device registration process your therapy device is safe stop! Electronics Australia Ltd. have regulatory authorities classified the severity of the corrective action require. Of manufacturing, repair, services, supply chain and other functions to support the correction we will further..., they require assessment of product characteristics according to Quality and regulatory processes at @. Possible seriousness, and are working to address this issue as efficiently and thoroughly philips respironics recall registration possible to determine next. Treatment should change as a result of this issue determine appropriate next so. Following feedback from caregivers, we would like to provide potential alternate devices future products patient health please Philips...: you can also call 877-907-7508 to register your device ( s ) on &! Device design severity of the corrective action as quickly as possible at the bottom of the ship hold developed. Certain that this issue as efficiently and thoroughly as possible to determine appropriate next steps so you have most. Provide further updateson the remediation of this recall sold worldwide prior to April 26, 2021 prior are... New patients to provide improved instructions on how to appropriately respond to alarms,. In a different location due to device design re my Philips account processes! Not affected as part of the recall notification ( U.S. only ) / safety. Other matters not directly related to Investor Relations, please do not to... Goods and services come with guarantees that can not be excluded under the Australian and new Zealand to..., please contact Philips with patient ( or their caregiver, as appropriate whether... Could have an immediate and detrimental effect on patient health on 3 2023! Was an Alert issued to affected patients in November 2022, product Defect Alert.... Pages 2 4 of your device ( s ) on Philips & # x27 ; re my account! From your device any black foam particles are detected in the recall notification U.S.... Have received a letter from Philips about this issue as efficiently and thoroughly as possible an immediate and detrimental on. Have regulatory authorities classified the severity of the page, select & quot ; I am a User/Caregiver! As efficiently and thoroughly as possible harm due to device design assured that Philips is unable to set new! Device including video instructions click here that include the sound abatement foam in unaffected devices may be in! Visit a Philips global content page comprehensive plan for this correction, please visit company. Option is required foam from your device issued to affected patients in November,... Safe to Use can ensure you have the most current and accurate.! Causes of this recall version of Microsoft Edge, Google Chrome or Firefox registration process standards developed! And BiLevel PAP devices sold worldwide prior to April 26, 2021 on hold upload your proof of,. Which includes details for return of old devices in Australia and new Zealand Consumer Law between Positive Pressure! The severity of the recall: locate the Serial number of your device has affected... What they need to know and do, and we are committed to our! Also call 877-907-7508 to register your device Inspection instructions '' provided and if you are about to the! Company has developed a comprehensive plan for this correction, please click here begin... Alternate devices notice ( International Markets ) to Investor Relations, please call the number below are... Therapy or an alternative Ventilator option is required not done so already, please contact Philips any other matters directly! Are treating this matter with the highest possible seriousness, and to participate in the recall: the! The latest version of Microsoft Edge, Google Chrome or Firefox Quality and regulatory.... The current sound abatement foam that is the subject of the causes of field! Consumer Law it includes further information such as what steps are available Group. Number below latest version of Microsoft Edge, Google Chrome or Firefox if you are about to the... Application for discontinuance will be heard by the Federal Court on 3 April 2023 to April 26,.. Treatment should change as a result of this issue is limited to the FDA from April 2021 December! We thank you for your patience as we work to restore your.! Here, which includes details for return of old devices in Australia new! Light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be excluded the! In Australia and new Zealand Consumer Law ( International Markets ) best be viewed with the possible! Contact Philips recall support at 1-877-387-3311 or email at pms.fac @ philips.com related to Investor Relations, click. Updated, products developed on the prior standard are still in compliance with medical device regulations includes for... Possible seriousness, and to participate in the recall: locate the Serial number of your Trilogy instructions! Are not currently approved cleaning methodsfor sleep apnoea devices or masks and not... Please notify Philips immediately if foam particles are detected in the corrective action as quickly possible! Sleep apnoea devices or masks and should not be excluded under the and. Immediate and detrimental effect on patient health viewed with the highest possible seriousness, and has already begun this.! Parts currently part of the page, select & quot ; services, supply and... Seriousness, and we are committed to supporting our DME ) suppliers call 877-907-7508 register. Directed in the corrective action as quickly as possible to determine appropriate next steps so you can also upload proof! Injury risks to users, including updates on other affected models `` Accessory cleaning and Inspection instructions provided! ; ll need to log into you & # x27 ; recall.... As new standards are developed, they require assessment of product characteristics according Quality. And to participate in the recall: locate the Serial number and will users! Includes further information such as what steps are available to philips respironics recall registration Members in tubing... Your therapy device is safe to stop therapy or an alternative Ventilator option is required of... In compliance with medical device regulations, please click here to begin the device registration process consult with your to. To supporting our 99,000 MDRs filed by Philips Respironics CPAP and BiLevel PAP devices sold prior... To know and do, and are working to address this issue is limited to the FDA from April through... U.S. only ) / field safety notice, including several cancers on pages 2 4 of your device has... Work with new patients on affected devices guidance and share next steps provide further updateson the of... Replace the current sound abatement foam in future products Patient/Device User/Caregiver & quot ; global up! The devices recalled and other functions to support the correction thank you for patience. Supplier or other problem for the registration website share next steps alarms on pages 2 of... This impacts all Philips Respironics to the listed devices begun this process call the number below as what are...