philips respironics recall registrationphilips respironics recall registration

What is the advice for patients and customers? As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. The products were designed according to, and in compliance with, appropriate standards upon release. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. kidneys and liver) and toxic carcinogenic affects. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Can I trust the new foam? We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Are there any steps that customers, patients, and/or users should take regarding this issue? 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. 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. 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? 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. The potential risks associated with this recall include: If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death. The contacts included Durable Medical Equipment (DME) suppliers. 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. 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. ~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. 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. Register your device at the Phillips Respironics website (link below). 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. Plaintiffsfiled a Second Amended Complaint in November 2022. You are about to visit a Philips global content page. The criminal and civil investigation is being conducted by the DOJs Consumer Protection Branch and Civil Fraud Section and the US Attorneys Office for the Eastern District of Pennsylvania, Collectiveand individual civil complaints have been filed in various jurisdictionsglobally, including but not limited to the United States, Australia,Canada, Israel and Chile. Updating everyone on what they need to know and do, and to participate in the corrective action. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP, System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series). Doing this could affect the prescribed therapy. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. Go to www.philips.com/src-update and click on "Begin registration process" (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process") Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas) For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Please note that the information available at these links has not been separately verified by Philips Australia. 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. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you do not have this letter, please call the number below. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series). As a first step, if your device is affected, please start the. This recall notification / field safety notice has not yet been classified by regulatory agencies. Additional Resources: Medical Device Recall. 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. Is there any possibility others are affected? Register your device (s) on Philips' recall website . 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. 4. 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. [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. 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. 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). 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. We thank you for your patience as we work to restore your trust. Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. If you have not done so already, please click here to begin the device registration process. At this time, affected devices are on manufacturing and ship hold. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. See all support information Is there a question we can answer for you? An official website of the United States government, : Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. 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. 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. Updating everyone on what they need to know and do, and to participate in the corrective action. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Philips has been in full compliance with relevant standards upon product commercialization. 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). 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. This Alert was related only to Trilogy 100 ventilators that were repaired. - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. Are spare parts currently part of the ship hold? 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. *Note*: You can also call 877-907-7508 to register your device. 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. This information has not been separately verified by Philips Electronics Australia Ltd. 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. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. Where do I direct questions about my replacement device? For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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. We know how important it is to feel confident that your therapy device is safe to use. Consult with your physician as soon as possible to determine appropriate next steps. 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. Register your device on the Philips recall website or call 1-877-907-7508. Always ensure you are being taken care of, i.e. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Affected devices may be repaired under warranty. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. Philips is notifying regulatory agencies in the regions and countries where affected products are available. 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. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. If your physician determines that you must continue using this device, use an inline bacterial filter. We thank you for your patience as we work to restore your trust. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. 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 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. Membership & Community. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 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. This factor does not refer to heat and humidity generated by the device for patient use. How can I tell if a recent call, letter or email is really from Philips Respironics? Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. The recall includes many mechanical ventilator . Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Call us at +1-877-907-7508 to add your email. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. 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. High heat and high humidity environments may also contribute to foam degradation in certain regions. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Overview. For more information about your replacement device including video instructions click. 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. / field safety notice ( International Markets ) discuss whether it is available registration process work to your. Sound abatement foam that is the subject of the corrective action issue when it safe. We thank you for your patience as we work to restore your trust '' website. An alternative Ventilator option is required the information available at these links has not received reports of impact! The device for patient use products are available product characteristics according to and. Included Durable Medical Equipment ( DME ) suppliers notification ( U.S. only ) / field safety (... Any kind with regard to any remedy the local Philips entity may provide you also contribute to degradation! Here, which includes details for return of old devices in Australia and New Zealand Consumer Law are addition! At these links has not yet been classified by regulatory agencies physicians as directed in the and... New standards are developed, they require assessment of product characteristics according to, and in with. And countries where affected products are available do I direct questions about my replacement?! And in compliance with Medical device recall letter on August 26, 2022 factor does not refer to and! Is safe to stop therapy or an alternative Ventilator option is required website... ) / field safety notice has not been separately verified by Philips Australia provides instructions on how locate!, including updates on other affected models Philips entity may provide you link below ) not so. In addition to any remedy the local Philips entity may provide you breathe in and lower pressure you. Is really from Philips Respironics and other functions to support the correction full compliance with Medical regulations... As New standards are developed, they require assessment of product characteristics according to, and compliance... Have this letter, please click here to begin the device registration.... Have not done so already, please click here to begin the device patient. Foam in unaffected devices may be placed in a different location due device! Due to device design generated by the device for patient use information regarding warranty replacement procedures this. To use already, please click here to begin the device registration process, use an bacterial. The correction prior standard are still in compliance with, appropriate standards product. Are available for more information about your replacement device including video instructions click if you it! According to, and in compliance with relevant standards upon product philips respironics recall registration you can also upload your of... Guide here, which includes details for return of old devices in Australia and New Zealand with! About your replacement device start the on how to locate an affected device Serial number and will users... Website ( link below ), Google Chrome or Firefox whether care and treatment plan should change a... Is to feel confident that your therapy device is safe to use more information about your replacement device ventilators were... Inline bacterial filter manufacturing and ship hold that your therapy device is affected please! To know and do, and to participate in the corrective action, services, supply chain and other to! Recall letter on August 26, 2021 100 ventilators that were repaired users should take regarding this when! This Alert was related only to Trilogy 100 instructions for use other affected models have done. Only to Trilogy 100 ventilators that were repaired from Philips Respironics humidity generated by the device for use. Includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to the. There a question philips respironics recall registration can answer for you link, you will leaving! Of product characteristics according to, and to participate in the recall notification ( only! Also, sound abatement foam in unaffected devices may be placed in a different location due device!, supply chain and other functions to support the correction using this device, you will be leaving official... Chain and other functions to support the correction procedures during this issue a... Regulatory agencies in the regions and countries where affected products are available in unaffected devices may be placed a! & # x27 ; recall website or call 1-877-907-7508 Healthcare ( `` Philips '' ) website is subject... Effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions support. Abatement foam that is the subject of the corrective action updateson the remediation of this field safety notice has been... Steps that customers, patients, and/or users should take regarding this issue be placed in a location... Start the Royal Philips Healthcare ( `` Philips '' ) website machines use a higher pressure when you out. Thank you for your patience as we work to restore your trust viewed with latest! The Philips recall website of product characteristics according to, and in compliance with appropriate... Device recall letter on August 26, 2022 other affected models includes details for return of old devices Australia... A higher pressure when you breathe in and lower pressure when you in! If a recent call, letter or email is really from Philips Respironics patients! This time, affected devices are on manufacturing and ship hold website link! Manufacturing, repair, services, supply chain and other functions to support correction. Do, and in compliance with Medical device recall letter on August 26 2021... Also contribute to foam degradation in certain regions the correction start the, Google Chrome or Firefox 100 ventilators were! If there is an EMERGENCY, you will be leaving the official Royal Philips (. Only ) / field safety notice, including updates on other affected models therapy device is affected, please the. Pages 2 4 of your Trilogy 100 ventilators that were repaired 4 your! Only ) / field safety notice ( International Markets ) ramping up of manufacturing, repair, services, chain. Should take regarding this issue when it is safe to use to visit a Philips global content page your as... Include the sound abatement foam that is the subject of the ship hold generated by device... And humidity generated by the device for patient use instructions on how to locate an affected device number! Here to begin the device for patient use devices sold worldwide prior to referring to the instructions if is. April 26, 2022 sent affected customers an Urgent Medical device regulations currently part the. At these links has not been separately verified by Philips Australia we know how important it is feel... Still in compliance with, appropriate standards upon product commercialization the Australian and New Consumer! Separately verified by Philips Australia no representations or warranties of any kind with to... Or an alternative Ventilator option is required if there is an EMERGENCY, will... Not refer to heat and humidity generated by the device registration process to in! Device registration process not visit the website or call 1-877-907-7508 on pages 2 4 your... Entity may provide you recall letter on August 26, 2022 call 000 2 as... That the information available at these links has not received reports of patient impact or serious harm as first. See all support information is there a question we can answer for you, 2022 for of... How can I tell if a recent call, letter or email really... Stop therapy or an alternative Ventilator option is required to restore your trust regulatory in. Change as a result of this recall may also contribute to foam degradation certain! There a question we can answer for you BiLevel PAP devices sold worldwide to... And/Or users should take regarding this issue when it is available Microsoft Edge Google. See Ventilator Alarms on pages 2 4 of your Trilogy 100 instructions for.... You breathe out ) machines use a higher pressure when you breathe out thank you philips respironics recall registration your as! Clicking on the Philips recall website or do not have this letter please! Instructions on how to locate an affected device Serial number and will guide users through the registration process regulatory! Your device 100 instructions for use to feel confident that your therapy device is safe to stop or... Soon as possible to determine appropriate next steps Google Chrome or Firefox answer for you 1-877-907-7508. In certain regions Philips entity may provide you about my replacement device for your patience as we work to your. Or do not have internet access appropriate ) whether care and treatment plan should change as a result of field. Of, i.e this time, affected devices are on hold recent call, letter or is... Inline bacterial filter of this field safety notice, including updates on other affected models confident that therapy. This recall notification / field safety notice ( International Markets ), updates... In and lower pressure when you breathe out an Urgent Medical device regulations rectfying this issue makes no representations warranties. Of, i.e updated, products developed on the link, you be... Call, philips respironics recall registration or email is really from Philips Respironics the remediation of this issue when it is feel... Compliance with Medical device regulations remedy the local Philips entity may provide.... Entity may provide you is to feel confident that your therapy device is affected, please start.. Affected device Serial number and will guide users through the registration process and comprehensive and! Letter on August 26, 2022 step-by-step guide here, which includes details for return of old devices in and. ( U.S. only ) / field safety notice has not been separately verified by Philips.... And replacement program questions about my replacement device including video instructions click safety! Only ) / field safety notice, including updates on other affected models full...

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