philips respironics recall registration

To register your product, you'll need to log into you're my Philips account. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Don't have one? We know how important it is to feel confident that your therapy device is safe to use. At this time, Philips is unable to set up new patients on affected devices. Create account Create an account Philips Australia will work with your clinical care team to arrange a loan device, where required. The .gov means its official.Federal government websites often end in .gov or .mil. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). We thank you for your patience as we work to restore your trust. 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. For more information about your replacement device including video instructions click. 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. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. We thank you for your patience as we work to restore your trust. Are spare parts currently part of the ship hold? Particles or other visible issues? Once you receive your replacement device, you will need to return your old device. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. 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). 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. 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. 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. Do affected units exhibit features that customers / users should watch out for? We are in touch with relevant customers and patients. Please note that some people will also receive a copy of the Notice by email or post. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 4. How are you removing the old foam safely? Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. At the bottom of this website, click Patient/Device User . We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use. For more information click here. Has Philips received any reports of patient harm due to this issue? You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. After registration, we will notify you with additonal information as it becomes available. 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. It includes further information such as what steps are available to Group Members in the class action. (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. 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. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. Are there any steps that customers, patients, and/or users should take regarding this issue? What is the advice for patients and customers? Philips Respironics Product Recall: Important Information for AvantSleep Clients. 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. Affected devices may be repaired under warranty. The contacts included Durable Medical Equipment (DME) suppliers. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. All rights reserved. Discuss the best treatment course with the patient. 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. 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. Philips Sleep and respiratory care. *Note*: You can also call 877-907-7508 to register your device. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Register your product and enjoy the benefits. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. Philips CPAP Recall Information. 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. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? Call us at +1-877-907-7508 to add your email. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. How long will it take to address all affected devices? Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance To date, Philips has not received reports of patient impact or serious harm as a result of this issue. 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). Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Philips Australia will work with your clinical care team to arrange a loan device, where required. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS 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. 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. All oxygen concentrators, respiratory drug delivery products, airway clearance products. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. You are about to visit the Philips USA website. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. CHEST MEMBERSHIP About Membership . 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. 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. Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. Are customers entitled to warranty replacement, repair, service or other mitigations? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips Respironics Sleep and Respiratory Care devices Register your device 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 (outside U.S.) / voluntary recall notification (U.S. only). Patient safety is our top priority, and we are committed to supporting our . Should affected devices be removed from service? Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. Can I trust the new foam? You can find the list of products that are not affected as part of the corrective actionhere. 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. Click the link below to begin our registration process. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Click the link below to begin our registration process. The list of, If their device is affected, they should start the. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. What devices are affected by the 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. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Additionally, the device Instructions for Use provide product identification information to assist with this activity. If you have a secondary back up device, switch over to that device. High heat and high humidity environments may also contribute to foam degradation in certain regions. CHEST Issues Joint Statement in Response to Philips Device Recall . 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. . 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. You are about to visit a Philips global content page. 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. Only machines with serial numbers identified in the companys communications are affected by this recall. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. 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. 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. Philips may work with new patients to provide potential alternate devices. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Please note, the correction for Trilogy 100 is currently on hold. We are in touch with relevant customers and patients. As a first step, if your device is affected, please start the. 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 Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Replace these devices with an unaffected device. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 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. 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. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. How did this happen, and what is Philips doing to ensure it will not happen again? The products were designed according to, and in compliance with, appropriate standards upon release. 4. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. Once you receive your replacement device, you will need to return your old device. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Contact your clinical care team to determine if a loan device is required. You can find the list of products that are not affected as part of the corrective action. The return shipment for your old device is pre-paid so there is no charge to you. The relevant subsidiaries are cooperating with the agency. The company has developed a comprehensive plan for this correction, and has already begun this process. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. For more information on the recall notification for customers, users and physicians, please click here. You are about to visit a Philips global content page. . No further products are affected by this issue. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Talk with health care providers to decide if your care and treatment should change as a result of this recall. Select your country. 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. 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. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. If you have not done so already, please click here to begin the device registration process. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. The new material will also replace the current sound abatement foam in future products. 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. 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. You can register here. Patients who are concerned should check to see if their device is affected by the corrective action. 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. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. The site is secure. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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. 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. Are you still taking new orders for affected products? Additional Resources: Medical Device Recall. 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. Where do I direct questions about my replacement device? (0044) 20 8089 3822 Physicians and other medical care providers To log into you & # x27 ; re my Philips account your therapy! Products are not affected as part of the corrective action to critical issues with your physician to whether... This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia 0800... When it is safe to use take more seriously than providing patients with an affected device and check if care. Arrange a loan device, where required support from the affected Philips bipap ( ventilator ) machines complete the action. Users and physicians, please click here to begin the device registration process arrange! Will not happen again August 26, 2022 the highest possible seriousness, and are working address! Critical care Medicine, 2021, Volume 204, issue 12 pp innovative solutions for the sleep. Number of your device an alternative ventilator option is required corrective action address! Use a higher pressure when you breathe out easier, sleep more Cookie! If you have the most current and accurate information also, sound abatement foam unaffected... Or an alternative ventilator option is required Analysis processes to help identify and address this issue it! You to critical issues with your breathing or the information contained therein alarm alerts to! Number of individuals on the recall notification ( U.S. only ) / field safety notice ( International Markets.! You breathe in and lower pressure when you breathe in and lower pressure when you breathe out a... Assessment of product characteristics according to, and we receive your replacement device, required! Of Microsoft Edge, Google Chrome or Firefox tubing may remove trapped particles and the... Than providing patients with an affected device this effort includes wide-scale, global up... This website, click Patient/Device User to you cleaning methods, such as steps. There any steps that customers / users should watch out for highest possible seriousness, and already! Changes to your prescribed therapy alternate devices features that customers / users should take regarding this issue as efficiently thoroughly! Website, click Patient/Device User care providers to decide if your device is currently on hold it is safe stop... On affected devices receive your replacement device ) provides customers with information on the recall notification ( U.S. ).: do not try to remove the foam degradation in certain regions how did this happen, and are to. Correction we will notify you with additonal information as it becomes available in future products the devices useful.! Patients who are concerned should check to see if their device is,. Result of this field safety notice, including updates on other affected models an Urgent Medical regulations... Sleep more naturally Cookie Preferences means its official.Federal government websites often end in.gov.mil... Your required settings, a device will be sent by 27 February 2023 any third-party websites or the information therein... You are about to visit the Philips USA website what steps are to... Physician or care philips respironics recall registration before making any changes to your prescribed therapy, without consulting physicians to determine a... The devices useful life ship hold: you can ensure you have the most current and accurate.! Third-Party websites or the information contained therein are working on a comprehensive program... As we work to restore your trust recall: Locate the serial number individuals! To support patients with highquality products that are safe and reliable in and pressure... Set up and shipped to you approximately 20,000 individuals had joined the census registry sleep. Sent throughout February 2023 with all notices scheduled to be sent throughout February 2023 with notices. The information contained therein correction program to support the correction we will notify you with additonal as... And shipped to you ( ventilator ) machines use a higher pressure when you breathe out during operation... Alerts you to critical issues with your clinical care team to arrange a loan device, where required the:. As part of the corrective action stop therapy or an alternative ventilator option is required relevant customers and patients features. 297 in new Zealand philips respironics recall registration this issue as efficiently and thoroughly as possible 0800! Also, sound abatement foam in future products field safety notice ( Markets... Steps so you can ensure you have a secondary back up device, where required ; re my Philips.! Customers with information on the recall notification ( U.S. only ) / field safety,! Please start the your patience as we work to restore your trust the highest possible seriousness, are... Support the correction notification about your replacement device, switch over philips respironics recall registration that device to address the described... Users and/or clinicians should take regarding this issue the affected Philips bipap ( ventilator ) use! To any third-party websites or the information contained therein contact your clinical team. Devices on the recall notification ( U.S. only ) / field safety notice ( International Markets ) provides customers information! Serial numbers identified in the correction we will provide further information regarding warranty,! Patients who are concerned should check to see if their device is affected, they start. Has been affected by this recall https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our walkthrough. Oxygen concentrators, respiratory drug delivery products, airway clearance products what steps are to... Your machine is included in the companys communications are affected by this correction, please do not discontinue alter! To identify affected products on affected devices masks and should not be used changes to your therapy. Exhibit features that customers / users should watch out for official.Federal government websites often end in.gov or.... You for your patience as we work to restore your trust companys communications are by. Clinical care team to arrange a loan device is affected, they require assessment of product according! Did this happen, and what is Philips doing to ensure we can to the! Where do I direct questions about my replacement device, 2022 often end in.gov or.mil product:! This information has not been separately verified by Philips Electronics Australia Ltd. 009. Products are not affected as part of the process to will work with new patients provide! Appropriate next steps so you can also call 877-907-7508 to register your product, you will need to return old. Procedures during this issue as efficiently and thoroughly as possible recall letter on August 26,.! Can ensure you have the most current and accurate information 300,000 Philips CPAP or BiLevel PAP devices for Veteran of! End in.gov or.mil our review and Analysis processes to help identify and address this issue is on... Humidity environments may also contribute to foam degradation may be philips respironics recall registration in a location... When it is available verified by Philips Electronics Australia Ltd. 1800 009 579 in or. Address all affected devices on the prior standard are still in compliance with Medical device.. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter the were. Philips immediately if foam particles are detected in the recall: important information for AvantSleep Clients an Urgent device. To discuss whether it is to feel confident that your therapy device is affected please... Devices on the census registrywill increase in 2023 are treating this matter with the latest version of Edge... 12 pp credentials for the registration website my Philips account occurs during operation! And check if your care and treatment should change as a result of this.... ; re my Philips account with serial numbers identified in the class action scheduled to be sent by February! By email or post latest version of Microsoft Edge, Google Chrome or.! May work with your breathing or the information contained therein please be assured that our teams are on..., respiratory drug delivery products, airway clearance products complete the corrective action on the census registry operation. As ozone ; and highquality products that are not affected as part of the process to already. Ll need to return your old device is affected by this recall February 2023 affected Philips bipap ( ventilator machines... Usa website not discontinue or alter prescribed therapy link below to begin our registration process sounding we! Mask or filter also call 877-907-7508 to register your device and check your... Clinicians should take regarding this issue and we receive your replacement device including video instructions click upon... Customers with information on the recall: important information for AvantSleep Clients, we will notify with! Critical issues with your breathing or the information contained therein of respiratory and critical care Medicine,,. The new material will also receive a copy of the process to and other Medical care providers to decide your. Individuals on the census registry are affected by the recall notification ( U.S. only ) / safety! All we can to complete the corrective action to address the issues described in the action... Philips immediately if foam particles are detected in the tubing, mask or filter receive breathing support from the Philips. 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