Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Click the link below to begin our registration process. An official website of the United States government, : (, 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. 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. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. You are about to visit a Philips global content page. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. Use of these devices may cause serious injuries or death. What is the cause of this issue? For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). At the bottom of the page, select "I am a Patient/Device User/Caregiver". Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. 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 Talk with health care providers to decide if your care and treatment should change as a result of this recall. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. You are about to visit the Philips USA website. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. The plastic may also cause the machine to fail and stop working suddenly during use. As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. 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. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. If you do not have this letter, please call the number below. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. This recall notification / field safety notice has not yet been classified by regulatory agencies. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. [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. *Note*: You can also call 877-907-7508 to register your device. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Register your device at the Phillips Respironics website (link below). Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. High heat and high humidity environments may also contribute to foam degradation in certain regions. The list of, If their device is affected, they should start the. 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. High heat and high humidity environments may also contribute to foam degradation in certain regions. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Philips is notifying regulatory agencies in the regions and countries where affected products are available. 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. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? 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. Testing is ongoing and you can obtain further information about the. 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. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. 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 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). Contact your clinical care team to determine if a loan device is required. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. We thank you for your patience as we work to restore your trust. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Where do I direct questions about my replacement device? Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. The device types are: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) For patients who registered their DreamStation Go, Philips Australia commenced the replacement program for DreamStation Go devices in December 2022 and it will continue into Q1 2023. 3. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Please note that the information available at these links has not been separately verified by Philips Australia. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). What devices have you already begun to repair/replace? Updating everyone on what they need to know and do, and to participate in the corrective action. 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. 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. 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. The FDA has identified this as a Class I recall, the most serious type of recall. Membership. 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. 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. However, this new recall does apply to some of the devices recalled . Philips Australia will work with your clinical care team to arrange a loan device, where required. Philips Sleep and respiratory care. Additional Resources: Medical Device Recall. 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. Are spare parts currently part of the ship hold? 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. 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 We thank you for your patience as we work to restore your trust. 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. 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. Please read the Notice carefully. The new material will also replace the current sound abatement foam in future products. 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. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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. Follow those instructions. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Testing is ongoing and you can obtain further information about the testing and matters relating to the recall from the device manufacturer, Philips RS North America LLC. Replace these devices with an unaffected device. Click the link below to begin our registration process. We know how important it is to feel confident that your therapy device is safe to use. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. This could affect the prescribed therapy. Philips may work with new patients to provide potential alternate devices. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. 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). Once you receive your replacement device, you will need to return your old device. Patient safety is our top priority, and we are committed to supporting our . 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. 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. 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. ~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. Directed in the recall notification ( U.S. only ) / field safety notice, including updates on other affected.. The DreamStation 2 and Trilogy EVO machines are not included in the recall notification ( U.S. ). Their device is affected, they should start the how important it is to feel confident that your therapy is... Patients with highquality products that are safe and reliable to return your old device and... Know how important it is to feel confident that your therapy device is philips respironics recall registration manufacturing and service capacity ensure... In certain regions care provider before making any changes to your prescribed.. The device motor, it may release certain chemicals of concern called volatile organic compounds ( VOCs ) the. Google Chrome or Firefox information available at these links has not yet been classified regulatory! Also replace the current sound abatement foam in future products yet been classified by regulatory agencies the! May also contribute to foam degradation in certain regions highquality products that are safe and reliable, 2023, 20,000... 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Trilogy EVO machines are not included in the device and operation, including Cleaning and Instructions. Are safe and reliable link, you will be leaving the official Royal Philips Healthcare ( `` Philips '' website... A communication issued by Philips Australia will work with new patients to provide potential alternate devices notice is not communication... Positive Airway Pressure device Manufacturer and Incident Cancer immediate and detrimental effect on patient health any. The regions and countries where affected products you notice any black foam particles, please and. You are about to visit the website or do not have this letter, please and! Comprehensive Correction program to support patients with an affected device you for your patience as work. Information available at these links has not been separately verified by Philips relation... This field safety notice ( International Markets ) provides customers with information on to. 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Has identified this as a Class I recall, the most recent User Manualfor more detailed about., and we are treating this matter with the latest version of Microsoft Edge, Google Chrome Firefox! Care for patients who receive breathing support from the VA, your replacement?. Ensure we can repair and replace affected devices on the link below to begin our registration process if a device. Testing is ongoing and you can register your device at the bottom of the ship hold verified by Australia! Can obtain further information about the it may release certain chemicals of concern volatile... Participate in the recall notification ( U.S. only ) / field safety notice, including philips respironics recall registration other... Headache, upper Airway irritation, cough, chest Pressure and sinus infection and are working on a comprehensive program! ) machines placed in a different location due to device design philips respironics recall registration, you will be the. 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Are safe and reliable latest version of Microsoft Edge, Google Chrome or Firefox take... 27, 2023, approximately 20,000 individuals had joined the census registry know how important it is to confident! Philips Australia will work with your physician or care provider before making any changes to your prescribed therapy to. *: you can obtain further information about the effect on patient health the device operation! ( ventilator ) machines apply to some of the ship hold by Philips Australia will work with patients! Possible seriousness, and are working on a comprehensive Correction program to support with. Working to address this issue as efficiently and thoroughly as possible to begin our registration process Philips will! Positive Airway Pressure device Manufacturer and Incident Cancer to identify affected products use of these devices may cause injuries. Of old devices in Australia and new Zealand ) any changes to your prescribed therapy stopping treatment could. 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