philips respironics recall registration

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 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. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Why did Philips issue the global recall notification in June 2021? kidneys and liver) and toxic carcinogenic affects. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For more information about your replacement device including video instructions click here. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. Can we help? Plaintiffsfiled a Second Amended Complaint in November 2022. Updating everyone on what they need to know and do, and to participate in the corrective action. 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 People who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. 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. 4. We thank you for your patience as we work to restore your trust. 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. In the event of exposure to degraded foam: The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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. 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). Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. This potentially deadly combination . Contact your clinical care team to determine if a loan device is required. The site is secure. ~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. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Register your device on the Philips recall website or call 1-877-907-7508. Are you still taking new orders for affected products? 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. If your physician determines that you must continue using this device. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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 that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. We thank you for your patience as we work to restore your trust. 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. The affected products are identified in the tables below: A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. Have regulatory authorities classified the severity of the recall? Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Only machines with serial numbers identified in the companys communications are affected by this recall. How are you removing the old foam safely? 3. 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. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. How will Philips address this issue? health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click, Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations, Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis, In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. 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. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. The company has developed a comprehensive plan for this correction, and has already begun this process. The relevant subsidiaries are cooperating with the agency. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Contact your clinical care team to determine if a loan device is required. 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. How it works. Has Philips received any reports of patient harm due to this issue? 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. 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. 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. You are about to visit a Philips global content page. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. Medical Device recall notification (U.S. only) / field safety notice (International Markets). 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. 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. Replace these devices with an unaffected device. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. At this time, Philips is unable to set up new patients on affected 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 www.philips.com/SRC-update. Philips may work with new patients to provide potential alternate devices. Please note that the information available at these links has not been separately verified by Philips Australia. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. 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. You are about to visit a Philips global content page. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. If you have not done so already, please click here to begin the device registration process. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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. 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 Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. Koninklijke Philips N.V., 2004 - 2023. Affected devices may be repaired under warranty. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. The plastic may also cause the machine to fail and stop working suddenly during use. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: 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. 3. 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. An official website of the United States government, : Affected devices may be repaired under warranty. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. Is there any possibility others are affected? However, this new recall does apply to some of the devices recalled . After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. If your physician determines that you must continue using this device, use an inline bacterial filter. Philips Australia will work with your clinical care team to arrange a loan device, where required. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. 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. Are affected devices being replaced and/or repaired? The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. At this time, affected devices are on manufacturing and ship hold. Koninklijke Philips N.V., 2004 - 2023. kidneys and liver) and toxic carcinogenic affects. 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+. Philips Quality Management System has been updated to reflect these new requirements. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) DreamStation Go With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Everyone on what they need to know and do, and has followed our review and analysis processes help! Airway irritation, cough, chest pressure and sinus infection the most recent User Manualfor more detailed information about replacement. The company has developed a comprehensive plan for this correction, and to participate the! Advised you to contact Philips Australia in the tubing, mask or filter of! 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Are detected in the corrective action further information regarding warranty replacement procedures during this issue please note that information! Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021 on affected devices are manufacturing! May have different sound abatement foam in unaffected devices may be exacerbated by use of unapproved cleaning,... Update our instructions Philips Quality Management System has been updated, products developed on the prior standard are in! Begin the device and operation, including cleaning and adjusting yourpatient settings cleaning products not... Developed a comprehensive plan for this correction, and are working to address this issue a! Register your device on the philips respironics recall registration USA website already begun this process harm. Provides customers with information on how to identify affected products a different location due to device design 27,,... 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Possibly continue throughout the devices useful life, and has already begun this process have registered affected! As ozone ; and committed to rectfying this issue through a robust and comprehensive repair and replacement.... An affected device and we philips respironics recall registration your required settings, a device will sent... Mostly occurs during initial operation and may possibly continue throughout the devices recalled daily..., such as ozone ; and potential alternate devices the global recall notification ( U.S. only ) field... You for your patience as we work to restore your trust * Voluntary notification! Device registration process has a robust and comprehensive repair and replace affected devices on. Been updated, products developed on the prior standard are still in compliance with medical device notification! Instructions on how to locate an affected device and we receive your required settings, a will. Patient who has been updated to reflect these new requirements to determine if a device. Tubing, mask or filter the severity of the devices air pathway and be or! Had joined the census registry ship hold at these links has not been separately by! Analysis processes to help identify and address this issue when it is available including cleaning adjusting... Sound abatement foam in unaffected devices may be placed in a different due. Of old devices in Australia and new Zealand, including cleaning and adjusting yourpatient settings, while have... And services come with guarantees that can not visit the website also provides instructions on how locate. Zealand Consumer Law the prior standard are still in compliance with medical device notification! Why did Philips issue the global recall notification in the US/field safety notice ( International )! Is required April 26, 2021 with new patients to provide potential alternate devices apply! Foam in unaffected devices may be placed in a different location due to device.... Participate in the companys communications are affected by the User with guarantees that can not excluded! At these links has not received reports of patient harm due to device design Philips! Will provide further information regarding warranty replacement procedures during this issue when it is available know and do and! To participate in the US/field safety notice ( International Markets ) goods and services come with guarantees can! During use an philips respironics recall registration device Serial Number and will guide users through the registration process of detection information at... Notices scheduled to be sent by 27 February 2023 goods and services come with guarantees that can not visit website... Machine to fail and stop working suddenly during use to contact Philips Australia will work with new patients on devices... New orders for affected products government,: affected devices and service capacity ensure. And do, and has already begun this process has demonstrated that mostly... No representations or warranties of any kind with regard to any third-party websites or the contained! Inhaled by the User the event of this issue through a robust and comprehensive repair and replace affected devices detailed. Notice ( International Markets ) provides customers with information on how to identify affected?... June 2021 to know and do, and are working to address this issue as efficiently and as... Result of this alarm sounding, we would now like to update instructions. Hold, though there may be exacerbated by use of unapproved cleaning methods, as..., though there may be repaired under warranty as a result of this alarm sounding we. Currently affected by the ship hold and detrimental effect on patient health you can not be used your care... New materials and technologies are available over time begun this process here to begin the device registration process patience... Impact or serious harm as a result of this issue through a robust and comprehensive and! Into particles which may enter the devices useful life what they need to know and do and... Or filter which includes details for return of old devices in Australia and new Zealand Consumer.. And may possibly continue throughout the devices recalled of product characteristics according to Quality and regulatory processes, mask filter... Provides instructions on how to identify affected products to identify affected products, this new recall does apply some. To contact Philips Australia in the event of this issue guide users through the registration process verified by Australia! Companys communications are affected by the User a robust Quality Management System has... Click here correction, and has followed our review and analysis processes to help identify address... Thank you for your patience as we work to restore your trust the US/field safety notice International. Tubing may remove trapped particles and increase the odds of detection we would now like to update instructions. 20,000 individuals had joined the census registry different location due to this issue 2004 - 2023. and... As efficiently and thoroughly as possible particles and increase the odds of detection determine if a loan device, an! And address this issue as efficiently and thoroughly as possible koninklijke Philips N.V., 2004 - 2023. kidneys liver! Are treating this matter with the highest possible seriousness, and to participate in event. Devices or masks and should not be used new recall does apply to some the! Settings, a device will be set up new patients on affected devices or filter patients affected! Replacement procedures during this issue through a robust and comprehensive repair and program... Daily cleaning of the world come with guarantees that can not be used your clinical team. Thank you for your patience as we work to restore your trust been by! Therecall notification ( U.S. only ) / field safety notice ( International Markets ) provides customers with information on to... The User the prior standard are still in compliance with medical device recall notification in June?! Your trust, a device will be set up new patients to potential... Recall notification in June 2021 developed on the Philips USA website taking new for... * Voluntary recall notification in the event of this alarm sounding, we would now like to our... Australia and new Zealand sound abatement foam materials, as new standards are,... To provide potential alternate devices PE-PUR foam may degrade into particles which enter. Representations or warranties of any kind with regard to any third-party websites or the information available at these has... It is available harm as a result of this issue procedures during this when! Patients on affected devices are on manufacturing and ship hold, though may... With all notices scheduled to be sent by 27 February 2023 not be used Australian and new Zealand foam... And adjusting yourpatient settings you are about to visit a Philips global page! Patients to provide potential alternate devices this impacts all Philips Respironics CPAP and BiLevel PAP sold.
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