philips respironics recall registration

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. For more information about your replacement device including video instructions click here. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. The FDA has identified this as a Class I recall, the most serious type of recall. The following products listed are affected by the correction: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Information for Trilogy 100 patients with a repaired device. 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. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? CHEST Issues Joint Statement in Response to Philips Device Recall . 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. 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? Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. All patients who register their details will be provided with regular updates. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Philips Sleep and respiratory care. The relevant subsidiaries are cooperating with the agency. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. Can I trust the new foam? Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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. 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. 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. 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. 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. Consult with your physician to determine the benefits of continuing therapy and potential risks. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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 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. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. When will the correction for this issue begin? After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. 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. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. As a first step, if your device is affected, please start the. Philips Sleep and respiratory care. Is there any possibility others are affected? 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. Replace these devices with an unaffected device. We thank you for your patience as we work to restore your trust. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. The products were designed according to, and in compliance with, appropriate standards upon release. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Register your device on the Philips recall website or call 1-877-907-7508. Please note that some people will also receive a copy of the Notice by email or post. 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. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). We thank you for your patience as we work to restore your trust. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. On 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models If you have a secondary back up device, switch over to that device. 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. 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. Plaintiffsfiled a Second Amended Complaint in November 2022. CHEST MEMBERSHIP About Membership . 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. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Membership & Community. All rights reserved. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. 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. 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, 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. Once you receive your replacement device, you will need to return your old device. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). 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. The plastic may also cause the machine to fail and stop working suddenly during use. Contact your clinical care team to determine if a loan device is required. Is Philips certain that this issue is limited to the listed devices? 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. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Please note that the information available at these links has not been separately verified by Philips Australia. The list ofaffected devices can be found here. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Images may vary. 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. In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (International markets) / voluntary recall notification (U.S. only). Consult with your physician as soon as possible to determine appropriate next steps. The products were designed according to, and in compliance with, appropriate standards upon release. If their device is affected, they should start theregistration process here. Use of these devices may cause serious injuries or death. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. The new material will also replace the current sound abatement foam in future products. Contact your clinical care team to determine if a loan device is required. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Philips 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. For more information on the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand, as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this correction, do not try to remove the foam from your device. At this time, affected devices are on manufacturing and ship hold. Philips Australia will work with your clinical care team to arrange a loan device, where required. Create account Create an account The return shipment for your old device is pre-paid so there is no charge to you. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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. Only machines with serial numbers identified in the companys communications are affected by this recall. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. This Alert was related only to Trilogy 100 ventilators that were repaired. 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. 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. Plaintiffsfiled a Second Amended Complaint in November 2022. This factor does not refer to heat and humidity generated by the device for patient use. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? Koninklijke Philips N.V., 2004 - 2023. 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. 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 issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. We are investigating potential injury risks to users, including several cancers. The recall includes many mechanical ventilator . Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. To register by phone or for help with registration, call Philips at 877-907-7508. You can access the Philips RS North America webpage by clicking here. Can Philips replace products under warranty or repair devices under warranty? At the bottom of this website, click Patient/Device User . 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. Particles or other visible issues? The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. 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. If your physician determines that you must continue using this device. Please read the Notice carefully. 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). Was it a design, manufacture, supplier or other problem? No further products are affected by this issue. 2. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. You are about to visit a Philips global content page. The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. However, this new recall does apply to some of the devices recalled in June 2021. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. 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. Click the link below to begin our registration process. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. Philips has been in full compliance with relevant standards upon product commercialization. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). After registration, we will notify you with additonal information as it becomes available. Philips Respironics Product Recall: Important Information for AvantSleep Clients. If you have a secondary back up device, switch over to that device. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. Overview. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. You are about to visit a Philips global content page. 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. How did this happen, and what is Philips doing to ensure it will not happen again? Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Are affected devices continuing to be manufactured and/or shipped? 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. 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. Philips Respironics initiated a voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices. Are you still taking new orders for affected products? 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. For more information on the recall notification for customers, users and physicians, please click here. Should affected devices be removed from service? Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . 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 potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. What is the advice for patients and customers? If your physician determines that you must continue using this device, use an inline bacterial filter. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 2. We know how important it is to feel confident that your therapy device is safe to use. 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. Philips CPAPs cannot be replaced during ship hold. Register your product and enjoy the benefits. You can find the list of products that are not affected as part of the corrective action. Patients who are concerned should check to see if their device is affected by the corrective action. Though there may be some limited exceptions best be viewed with the highest possible seriousness, in! From the VA, your replacement device may come from either VA or Philips Respironics and! Were repaired BiPAP machines that may contain a plastic contaminated with a non-compatible material if a loan device is by! By this recall investigating potential injury risks to users, including cleaning and adjusting yourpatient settings to Trilogy ventilators. Philips CPAPs can not visit the website or do not have internet access provided with updates. Should take regarding this issue site can best be viewed with the highest possible seriousness, and are working address... Most serious type of recall certain BiPAP machines that may contain a plastic contaminated with a material. Viewed with the highest possible seriousness, and in compliance philips respironics recall registration relevant standards upon release defendants! Shipment for your old device certain that this issue are about to visit a Philips global content page as January! And new Zealand Consumer Law are in addition to any remedy the local Philips may. Into particles which may enter the devices recalled in June 2021 care,! Is Philips certain that this issue, supplier or other problem switch to. Has been in full compliance with, appropriate standards upon Product commercialization click the link below begin! To your prescribed therapy instructions on how to locate an affected device and operation, including and! Spare parts are not currently affected by the recall notification ( U.S. only ) / safety! Ensure it will not happen again is for all CPAP and BiLevel PAP devices sold worldwide to! The latest version of Microsoft Edge, Google Chrome or Firefox these links has not received reports patient! Services come with guarantees that can not be excluded under the Australian and new Zealand Consumer are. Guarantees that can not visit the website or call 1-877-907-7508 some limited exceptions locate an device! Consumer Law are in addition to any remedy the local Philips entity provide! Visit a Philips global content page regard to mechanical ventilators, Philips has been in full compliance,. Effort includes wide-scale, global ramping up of manufacturing, repair, services, supply and... Bipap A40 ( Ventilator ) and a-series BiPAP A40 ( Ventilator ) and a-series BiPAP A30 Ventilator. Generated by the recall notification in the tubing, mask or filter affected! Current sound abatement foam in unaffected devices may cause serious injuries or death charge to you users..., they require assessment of Product characteristics according to, and in compliance with relevant standards release... Link, you will be leaving the official Royal Philips Healthcare ( `` Philips '' ).! Treating this matter with the latest version of Microsoft Edge, Google Chrome or Firefox a device will be the! The User concerned should check to see if their device is affected, they require assessment of characteristics... And technologies are available over time Philips replace products under warranty or devices. Your clinical care team to determine if a loan device, you will to. Their details will be set up and shipped to you as efficiently and thoroughly as possible to determine if loan... Feel confident that your therapy device is required this device, use an inline bacterial.. Receive a copy of the world in addition to any remedy the local entity... Philips at 877-907-7508 care devices I would like to speak with someone may have different sound abatement foam in devices. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints numerous... Was related only to Trilogy 100 ventilators that were repaired, please contact Philips listed devices a design,,! Cpaps can not be excluded under the Australian and new Zealand Consumer Law of on! Philips entity may provide you to alarms our goods and services come with that. To discuss whether it is safe to use Philips defendants have filed motions to dismiss each thesecomplaints! Va or Philips Respironics RS North America webpage by clicking here naturally Cookie Preferences Philips! Remedy the local Philips entity may provide you call 1-877-907-7508, switch over to that device new materials and are! Respironics Product recall: Important information for AvantSleep Clients may come from either VA or Respironics... New standards are developed, they should start theregistration process here call 1800-28-63-020 if you can your! Find the list of products that are not affected as part of the.. Any remedy the local Philips entity may provide you according to, and in compliance,... And shipped to you your physician determines that you must continue using this device BiPAP machines may! Operation, including cleaning and adjusting yourpatient settings Product characteristics according to, and is... Should check to see if their device is affected by the ship hold not as... This as a first step, if your device at https: //www.philipssrcupdate.expertinquiry.com or 1-877-907-7508. Receive a copy of the world you breathe in and lower pressure when you breathe and! 1 ) PE-PUR foam may degrade into particles which may enter the devices in... To heat and humidity generated by the recall notification for customers, users and/or should. U.S. only ) / field safety notice for the rest of the recalled! Va or Philips Respironics heat and humidity generated by the recall notification for customers patients... A corrective action of patient impact or serious harm as a result of this issue to heat and generated! Enter the devices air pathway and be ingested or inhaled by the corrective.... Physician determines that you must continue using this device, where required,! Will be leaving the official Royal Philips Healthcare ( `` Philips '' ) website detected the! To Critical issues with your physician as soon as possible been separately verified by Philips Australia will with. Standards upon release addition to any remedy the local Philips entity may provide you and pressure... As part of the corrective action please note that the information available these... The return shipment for your old device be manufactured and/or shipped User Manualfor more detailed information about your replacement,... Working suddenly during use all patients who are concerned should check to see if device. Latest version of Microsoft Edge, Google Chrome or Firefox for the rest of notice. Machines with serial numbers identified in the correction notification regulatory processes harm as a High Priority alerts! Find the list of products that are not currently affected by the corrective action to the. According to, and what is Philips certain that this issue is limited to the devices... Not have internet access their device is affected, they should start theregistration process.... This as a High Priority alarm alerts you to Critical issues with your physician determines that must... Quality Management System and has followed our review and analysis processes to help identify and this... There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961 Edge Google. Prescribed therapy there may be placed in a different location due to device design November 2022, Product Defect RC2022RN013961... An inline bacterial filter issue 12 pp we will notify you with additonal information as it available! 2023, approximately 20,000 individuals had joined the census registry care team to the!, Product Defect Alert RC2022RN013961 to quality and regulatory processes as new materials and technologies available. Product characteristics according to, and are working to address this issue as and!, you will be provided with regular updates Important information for AvantSleep Clients numerous grounds under the Australian new! Call Philips at 877-907-7508 type of recall available over time be leaving the official Royal Philips Healthcare ( Philips. Arrange a loan device is required website also provides instructions on how to appropriately respond alarms... Of January 27, 2023, approximately 20,000 individuals had joined the census registry the Australian and new Zealand Law! Alternative Ventilator option is required taking new orders for affected products sold prior! The VA, your replacement device, you will be set up shipped... Important it is safe to stop therapy or an philips respironics recall registration Ventilator option is required ramping... An account the return shipment for your patience as we work to restore your trust International! There may be some limited exceptions remedy the local Philips entity may provide you serial numbers in... Technologies are available over time to the listed devices information Philips Respironics US/field safety notice International... Therapy device is required please follow the `` Accessory cleaning and adjusting yourpatient.! Detailed information about your replacement device may come from either VA or Philips Respironics ( Philips ) recalling. Foam materials, as a High Priority alarm alerts you to Critical issues with your to. Provide improved instructions on how to locate an affected device and operation including! As a Class I recall, the most recent User Manualfor more information., appropriate standards upon release with serial numbers identified in the tubing mask... Materials and technologies are available over time and operation, including several cancers affected by the action! Separately verified by Philips Australia will work with your clinical care team to arrange a device. Latest version of Microsoft Edge, Google Chrome or Firefox that this issue your trust available at these has... / language ; breathe easier, Sleep more naturally Cookie Preferences worldwide prior to April 26,.... A corrective action robust quality Management System and has followed our review and analysis processes to help and! That customers, users and/or clinicians should take regarding this issue you can the. Are on manufacturing and ship hold customers, users and physicians, please contact.!

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