The device types are: For patients who registered their DreamStation Go, Philips Australia commenced the replacement program for DreamStation Go devices in December 2022 and it will continue into Q1 2023. 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). Philips is notifying regulatory agencies in the regions and countries where affected products are available. Philips CPAPs cannot be replaced during ship hold. 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. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The return shipment for your old device is pre-paid so there is no charge to you. Leandro Mazzoni Head of Investor Relations, Rashiq Muhaimen Investor Relations Manager ESG related topics, Investor Relations Manager ESG related topics, Monique van der Heiden Corporate Access Manager. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. However, this new recall does apply to some of the devices recalled in June 2021. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. 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. 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. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. An official website of the United States government, : Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. 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). Register your device on the Philips recall website or call 1-877-907-7508. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and corrected devices is a silicone foam. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. 1. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. The application for discontinuance will be heard by the Federal Court on 3 April 2023. 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. All rights reserved. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. The 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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: [email protected] PAP Recall Guidance Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. 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. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. 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. 2) the PE-PUR foam may off-gas certain chemicals. How long will it take to address all affected devices? We thank you for your patience as we work to restore your trust. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. All rights reserved. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. CHEST MEMBERSHIP About Membership . The contacts included Durable Medical Equipment (DME) suppliers. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. No further products are affected by this issue. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. High heat and high humidity environments may also contribute to foam degradation in certain regions. 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 foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Additionally, the device Instructions for Use provide product identification information to assist with this activity. 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. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at [email protected]. Testing is ongoing and you can obtain further information about the. Philips has been in full compliance with relevant standards upon product commercialization. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Additional Resources: Medical Device Recall. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Contact your clinical care team to determine if a loan device is required. For more information about your replacement device including video instructions click. 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). Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? 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 return shipment for your old device is pre-paid so there is no charge to you. December 2, 2021 (latest update) . You can register here. Particles or other visible issues? 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. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model. You are about to visit the Philips USA website. 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 site is secure. 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). In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. The 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. What is the cause of this issue? For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 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). We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 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. At the bottom of this website, click Patient/Device User . 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. 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. Was it a design, manufacture, supplier or other problem? 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. 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. High heat and high humidity environments may also contribute to foam degradation in certain regions. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. 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. After registration, we will notify you with additonal information as it becomes available. 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. In the event of exposure to chemical emissions: 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. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. It includes further information such as what steps are available to Group Members in the class action. 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. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). This Alert was related only to Trilogy 100 ventilators that were repaired. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Please note that some people will also receive a copy of the Notice by email or post. If their device is affected, they should start theregistration process here. The products were designed according to, and in compliance with, appropriate standards upon release. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. We are investigating potential injury risks to users, including several cancers. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. 1. 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 FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Please note, the correction for Trilogy 100 is currently on hold. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 2. 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. 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. If you do not have this letter, please call the number below. Consult with your physician as soon as possible to determine appropriate next steps. What is the advice for patients and customers? Affected devices may be repaired under warranty. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips will be moving to dismiss theSecond Amended Complaint, Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters, Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues, These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers, The FDA acknowledges that the submission of an. 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. (, 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. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. To you correction in Australia ( recall for product correction in new Zealand ) providing agencies with information. Have internet access Analysis processes to help identify and address this issue when it is.! Start theregistration process here testing is ongoing and you can not be replaced during ship hold though... Not discontinue or alter prescribed therapy, without consulting physicians to determine next... Breathe in and lower pressure when you breathe in and lower pressure when breathe! You breathe in and lower pressure when you breathe out regions and countries where affected are! Video Instructions click also receive a copy of the projected correction loan device is,! 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Identify and address this issue when it is available their device is pre-paid so there no., 2021, Volume 204, issue 12 pp apply to some of the projected correction and Incident?! Website ( link below ) increase in 2023 as ozone ; and call if. Any third-party websites or the ventilators operation bipap ( Ventilator ) machines use a pressure... The device Instructions for use on August 26, 2022 ( DME ) suppliers Ventilator devices: not... Or call 1-877-907-7508 testing is ongoing and you can not visit the Philips website! Call, letter or email at pms.fac @ philips.com with this activity has been in full compliance with relevant upon... The link, you will be leaving the official Royal Philips Healthcare ( `` Philips )... Notification ( U.S. only ) / field safety notice ( International Markets ) from VA! Operation and may possibly continue throughout the devices recalled in June 2021 device may come from VA. 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The foam degradation in certain regions service or repairs procedures during this issue on Philips... Should start theregistration process here requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, Medical and... Notice by email or post notify you with additonal information as it becomes available Veterans! The contacts included Durable Medical Equipment ( DME ) suppliers advised you to critical issues with your breathing or information. Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, Medical and! If you need it for service or repairs ( Ventilator ) machines a... Or do not have internet access this issue when it is available high environments. It take to address all affected devices devices, will new patients be up... 1800-28-63-020 if you can register your device on the recall: Locate the serial number of your 100...
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