If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Always ensure you are being taken care of, i.e. 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. 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. For Spanish translation, press 2; Para espaol, oprima 2. . Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. 2) the PE-PUR foam may off-gas certain chemicals. 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. We are in touch with relevant customers and patients. 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. Philips Australia will work with your clinical care team to arrange a loan device, where required. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 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. Please note, the correction for Trilogy 100 is currently on hold. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. 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. Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 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. 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. Philips CPAPs cannot be replaced during ship hold. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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. 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. Use of these devices may cause serious injuries or death. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . 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. Are affected devices continuing to be manufactured and/or shipped? Contact your clinical care team to determine if a loan device is required. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. [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. Register your device at the Phillips Respironics website (link below). 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. The plastic may also cause the machine to fail and stop working suddenly during use. 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. 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. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. The recall is a high-profile problem that has affected millions of patients in the U.S. and other countries for almost two years, and those . Was it a design, manufacture, supplier or other problem? BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. This Alert was related only to Trilogy 100 ventilators that were repaired. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. 4. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. You can find the list of products that are not affected as part of the corrective actionhere. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). 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. What is the cause of this issue? 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. 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. Patient safety is our top priority, and we are committed to supporting our . High heat and high humidity environments may also contribute to foam degradation in certain regions. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. The FDA has identified this as a Class I recall, the most serious type of recall. At the bottom of this website, click Patient/Device User . 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. Updating everyone on what they need to know and do, and to participate in the corrective action. What is the advice for patients and customers? If you have a secondary back up device, switch over to that device. 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. The letter offered the following recommendations. Royal Philips (NYSE: PHG) is promising a turnaround from its bottom-line woes, which began with one of the largest medical devices recalls in recent history. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 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. 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. 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. 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. Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. If your physician determines that you must continue using this device. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Philips Quality Management System has been updated to reflect these new requirements. 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. Only machines with serial numbers identified in the companys communications are affected by this recall. You can find the list of products that are not affected as part of the corrective action. 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. Why did Philips issue the global recall notification in June 2021? CHEST Issues Joint Statement in Response to Philips Device Recall . Do not stop or alter your prescribed ventilator therapy. (, 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. 1. Follow the steps for registering your device. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? Philips CPAP Recall Information. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. These printed instructions include a QR code you can scan, which will take you to an online instructional video. Philips has been in full compliance with relevant standards upon product commercialization. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. To register your product, you'll need to log into you're my Philips account. If their device is affected, they should start theregistration process here. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. After registration, we will notify you with additonal information as it becomes available. Is Philips certain that this issue is limited to the listed devices? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). 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. Before sharing sensitive information, make sure you're on a federal government site. The new material will also replace the current sound abatement foam in future products. June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen; At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). 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 of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? Patients who are concerned should check to see if their device is affected by the corrective action. Consult with your physician as soon as possible to determine appropriate next steps. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Call us at +1-877-907-7508 to add your email. 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. You are about to visit the Philips USA website. Please note, the correction for Trilogy 100 is currently on hold. Selected products At this time, Philips is unable to set up new patients on affected devices. 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. Updating everyone on what they need to know and do, and to participate in the corrective action. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Philips is notifying regulatory agencies in the regions and countries where affected products are available. (0044) 20 8089 3822 Physicians and other medical care providers Philips has been in full compliance with relevant standards upon product commercialization. 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). [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. To register by phone or for help with registration, call Philips at 877-907-7508. 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. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? What happens after I register my device, and what do I do with my old 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. For more information about your replacement device including video instructions click. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. Are spare parts currently part of the ship hold? 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. [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. 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. 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. 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. 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. 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. 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. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. The site is secure. We know how important it is to feel confident that your therapy device is safe to use. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Additionally, the device Instructions for Use provide product identification information to assist with this activity. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. For more information click here. 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 have a secondary back up device, switch over to that device. 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. All rights reserved. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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. 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. Medical Device 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. 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. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. The relevant subsidiaries are cooperating with the agency. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. Philips Australia will work with your clinical care team to arrange a loan device, where required. Can Philips replace products under warranty or repair devices under warranty? 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. 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). The return shipment for your old device is pre-paid so there is no charge to you. Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. 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