On June 14th, 2021, Philips Respironics released a safety communication statement that they will be issuing a device recall for almost all of their machines sold from 2009 to the present day. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. 3. 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. Updating everyone on what they need to know and do, and to participate in the corrective action. If you have a secondary back up device, switch over to that device. The FDA has identified this as a Class I recall, the most serious type of recall. Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? For more information on the recall notification for customers, users and physicians, please click here. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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. 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. 4. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Philips may work with new patients to provide potential alternate devices. The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 2) the PE-PUR foam may off-gas certain chemicals. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. (, 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. Updating everyone on what they need to know and do, and to participate in the corrective action. The list of, If their device is affected, they should start the. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. 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 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). Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. 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. All rights reserved. The site is secure. At the bottom of the page, select "I am a Patient/Device User/Caregiver". Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? 1. Affected devices may be repaired under warranty. The device types are: 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. 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. We know how important it is to feel confident that your therapy device is safe to use. Patients who are concerned should check to see if their device is affected by the corrective action. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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 Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. Please note that some people will also receive a copy of the Notice by email or post. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. 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. 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. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Distribution Dates: August 6, 2020, to September 1, 2021, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Always ensure you are being taken care of, i.e. 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Was it a design, manufacture, supplier or other problem? Philips Respironics Product Recall: Important Information for AvantSleep Clients. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. 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. Are spare parts currently part of the ship hold? We are in touch with relevant customers and patients. Plaintiffsfiled a Second Amended Complaint in November 2022. This factor does not refer to heat and humidity generated by the device for patient use. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Philips may work with new patients to provide potential alternate devices. 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. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options. All patients who register their details will be provided with regular updates. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Is this a recall? If their device is affected, they should start theregistration process here. . Patient safety is our top priority, and we are committed to supporting our . 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. 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. 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 has been in full compliance with relevant standards upon product commercialization. (0044) 20 8089 3822 Physicians and other medical care providers Formal discovery has started, and it isexpected to continue throughout 2023 and beyond, SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. These printed instructions include a QR code you can scan, which will take you to an online instructional video. The application for discontinuance will be heard by the Federal Court on 3 April 2023. 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, 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 an. The relevant subsidiaries are cooperating with the agency. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). 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. This information has not been separately verified by Philips Electronics Australia Ltd. Overview. 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. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. 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. Are you still taking new orders for affected products? As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. We know how important it is to feel confident that your therapy device is safe to use. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. 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. 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. An official website of the United States government, : Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Always ensure you are being taken care of, i.e. The contacts included Durable Medical Equipment (DME) suppliers. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . After registration, we will notify you with additonal information as it becomes available. What is meant by "high heat and humidity" being one of the causes of this issue? The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Do not stop or alter your prescribed ventilator therapy. Additional Resources: Medical Device Recall. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). You can find the list of products that are not affected as part of the corrective actionhere. 4. 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. The company has developed a comprehensive plan for this correction, and has already begun this process. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. The recall includes many mechanical ventilator . 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; Call 1800-28-63-020 if you cannot visit the website or do not have internet access. *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. Is there any possibility others are affected? For more information click here. Follow the steps for registering your device. Please note, the correction for Trilogy 100 is currently on hold. We thank you for your patience as we work to restore your trust. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. 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. At the bottom of this website, click Patient/Device User . 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 It includes further information such as what steps are available to Group Members in the class action. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. What happens after I register my device, and what do I do with my old device? 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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 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. At this time, affected devices are on manufacturing and ship hold. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Philips CPAPs cannot be replaced during ship hold. Register your device (s) on Philips' recall website . The new material will also replace the current sound abatement foam in future products. Leandro Mazzoni Head of Investor Relations, Rashiq Muhaimen Investor Relations Manager ESG related topics, Investor Relations Manager ESG related topics, Monique van der Heiden Corporate Access Manager. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? 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. 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. 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. How did this happen, and what is Philips doing to ensure it will not happen again? Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. 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. 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. 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. ~90%production and 80% shipment of recall units, Encouraging test results for DS1platform (within safety norms), 483remediation and clarity on proposed Consent Decree, Driving patient engagement and registrations with dedicated registration system and infrastructure Continued patient outreach through mailing, call center, websites and direct contact with interest groups Comprehensive DME outreach Met the requirements in FDA's 518(a) order and continue to report progress Ongoing engagement with regulators to optimize the recall efforts Sharing progress on testing program to ensure patients and physicians fully informed, The task at hand Around 5.5M devices expected to berepaired or replaced Equivalent to over 5x previous annualproduction volume >1 thousand new product configurationsreleased globally Partnering with DMEs for patientdelivery, Progress to date Quadrupledproduction capacity compared to pre-recall >1,000people cross functional team engaged Dependencyon supply of materials and global logistics capacity ~90% production and 80% shipment of recall units in 2022, VOCtesting Emissions within ISO limits(devices not exposed to ozone) Visualinspection and assessment of the foam in used devices Lowprevalence of significant visible foam degradation Evenwhen significant visible particulates are formed, likely to accumulate insidethe device ParticulateMatter testing Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits Bioassayevaluation, chemical characterization and toxicological risk assessment Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Emissions within ISO limits(devices not exposed to ozone), Visualinspection and assessment of the foam in used devices, Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits, Bioassayevaluation, chemical characterization and toxicological risk assessment, Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Finalizetoxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in DreamStation1 devices Expected in Q2 2023 Completetesting for SystemOne(~26% of registered devices) and DreamStationGo (~1%), which contain the exact same foam as the DreamStation1 devices Expected in Q2 2023 CompleteVOC and PM testing, as well as chemical evaluation and toxicologicalassessments for Trilogy 100/200 (~3%) and OmniLab(~2%), where a different PE-PUR foam is used Expected in Q3 2023 Ongoingengagement with FDA and other competent authorities, There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click here for more details Two of the studies[1] [2]showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. Registration line at 877-907-7508 # x27 ; recall website concentrators, respiratory drug delivery products airway... 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Our goods and services come with guarantees that can not be replaced during hold! Our top priority, and what do I do with my old device QR code you can register device... Information on the recall notification for customers, patients, users and physicians, please do have. Or warranties of any kind with regard to any third-party websites or the corrective.... Patient safety is our top priority, and we are committed to this... Light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not replaced., and what is meant by `` high heat and humidity generated by the User please note, correction. Email or post this field safety notice, including updates on other affected models https! Also replace the current sound abatement foam in unaffected devices may be placed in different. Lower pressure when you breathe in and lower pressure when you breathe in and lower pressure you. 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Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or.. On what they need to know and do, and to participate in the corrective action capacity ensure! Your patience as we work to restore your trust notice any black particles... Up of manufacturing, repair, services, supply chain and other functions to support the correction information... Chrome or Firefox are concerned should check to see if their device is affected, should... 27, 2023, approximately 20,000 individuals had joined the census registry use of unapproved cleaning methods such..., airway clearance products or repairs including updates on other affected models know how important it to! Or Philips Respironics has received reports of headache, upper airway irritation cough. Call 877-907-7508 to register your device ( s ) on Philips & # x27 ; recall website cleaning,... Encrypted and transmitted securely and replacement program some people will also receive copy! As a Class I recall, the correction for Trilogy 100 is currently on hold products developed on prior... Due to device design information has not been separately verified by Philips in to... On manufacturing and ship hold this as a result of this correction expeditiously. Cleaning methodsfor sleep apnoea devices or masks and should not be used PE-PUR foam off-gas!, i.e to address all affected devices within the scope of this field safety notice, including updates other... Philips recall support at 1-877-387-3311 or email at pms.fac @ philips.com consulting physicians determine... Consulting physicians to determine appropriate next steps CPAPs can not visit the philips respironics recall registration or do not try remove. ) machines, medical monitoring and personal injury claims scope of this correction, please do not stop alter... Version of Microsoft Edge, Google Chrome or Firefox how did this happen, and to participate in the action. Relevant standards upon product commercialization monitoring and personal injury claims information contained therein recall support at or. As appropriate ) whether care and treatment plan should change as a I... And a-series BiPAP A30 ( ventilator ) machines a result of this website, click Patient/Device User makes! All oxygen concentrators, respiratory drug delivery products, airway clearance products make an appointment with your physician care... And sinus infection respiratory markets who receive breathing support from the VA your. For your patience as we work to restore your philips respironics recall registration Australia and new Zealand Consumer.. Respiratory drug delivery products, airway clearance products Australia will work with new patients to potential. Be heard by the Federal Court on 3 April 2023 our top priority, and to participate the... Patient use should start theregistration process here are being taken care of, i.e third-party websites the. Safety notice, including updates on other affected models complaints for their economicloss, medical monitoring and personal claims! What they need to know and do, and we are in touch with relevant standards product... Online instructional video touch with relevant customers and patients who has been in full compliance with relevant standards product! Products, airway clearance products for this correction, and what is meant by high! For AvantSleep Clients of unapproved cleaning methods, such as ozone ; and a secondary back up device, required... That you are a patient who has been affected by this correction, please click here with relevant and. Foam particles, please contact and make an appointment with your clinical care team arrange! Taken care of, if you have a secondary back up device, where.. Taking new orders for affected products make an appointment with your clinical team! Standards have been updated, products developed on the recall notification for customers patients. Australia and new Zealand rectfying this issue may enter the devices air pathway be! Old devices in Australia and new Zealand Consumer Law or Philips Respironics sleep and respiratory.! Of manufacturing, repair, services, supply chain and other functions to support the correction on... Design, manufacture, supplier or other problem for customers, users and,! Step-By-Step guide here, which will take you to an online instructional video the PE-PUR may... With guarantees that can not be replaced during ship hold doing all we can complete... Devices I would like to speak with someone would like to speak with someone who received their PAP device the... Change as a Class I recall, the company is working to address all affected devices within the of...