In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. 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. Canada; Ontario; Brampton; Westgate Real Estate; City Guide Real Estate & MLS Listings in Westgate, Brampton . Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. Or call us at: 1-800-345-6443, Options 4-6-1. Information for clinicians, all in one place. 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. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Call 1800-220-778 if you cannot visit the website or do not have internet access. The web servers are located in the United States and are reachable through the IP address 34.117.168.233. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Call 1800-220-778 if you cannot visit the website or do not have internet access. *This number is ONLY for patients who have received a replacement machine. This factor does not refer to heat and humidity generated by the device for patient use. Are affected devices safe for use? Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. At this time, Philips is unable to set up new patients on affected devices. Monday-Friday: 8am-8pm ET, except holidays. 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. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. As part of the remediation process, customers and patients will be provided with more information on the next steps to implement the permanent solution as it becomes available. Patients who are concerned should check to see if their device is affected. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. If you currently use a Philips CPAP or BiPAP device, please visit Philips . RECALL NOTICE: PHILIPS RESPIRONICS CPAP AND BIPAP DEVICES . 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 remediation process. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips Quality Management System has been updated to reflect these new requirements. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. 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 will provide further information regarding warranty replacement procedures during this issue when it is available. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly. 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 remediation program to support patients with an affected device. What is the safety hazard associated with this issue? Contact us to let us know you are aware of the Philips recall (if you have not already). 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 remediation process. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. Note: Tape switch is not included. 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. Updated as of 9/1/2021. PHILIPS RESPIRONICS Voluntary RECALL Information for patients asking questions: Philips Respironics at (877) 907-7508 or visit the website: https://www.usa.philips . Best CPAP Machines of 2023. You can find the list of products that are not affected here. For Distributor Partners (Ballasts, Lamps and Luminaires) 1-855-486-2216 . Are customers entitled to warranty replacement, repair, service or other mitigations? Can I trust the new foam? As a result, testing and assessments have been carried out. Register any Philips device you wish to have repaired/replaced. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). We estimate that between 3 and 4 million patients are affected, half of whom are in the U.S. For example, spare parts that include the sound abatement foam are on hold. You may also gain access to the lastest savings, promotions, and product news, simply by choosing to receive future correspondence from Philips. Therecall 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, as well as instructions on actions to be taken. Working to reach everyone affected so they understand the situation and know what they need to do, starting with the registration of the affected devices. For other inquiries or to speak with a support specialist, you can also call (0044) 20 8089 3822. 6.18.2021. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. We are not taking new orders at this time, and we have stopped all new shipments temporarily, in order to support the field safety notice. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. Has Philips received any reports of patient harm due to this issue? Submit it online 24/7 at our self-service portal (a user account is required). In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. 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. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. On December 8, 2022, Apria was notified by Philips Respironics of a new nationwide recall of these remediated Trilogy 100/200 ventilator devices. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Using alternative treatments for sleep apnea. 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 remediation process. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. The . Click the link below to begin our registration process. PHILIPS RESPIRONICS PAP DEVICE RECALL INFO: Updated 03/11/2022 (updates are in bold) Update March 14, 2022: In response to numerous reports of problems people have had This is a potential risk to health. As a result of extensive ongoing review, on June 14 . PAPs are assigned to clients by Philips and are sent to us at random; we will . Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? Philips CPAPs cannot be replaced during ship hold. Are affected devices being replaced and/or repaired? Therefore, PM service cannot be completed until we have authorization for the new foam design with Trilogy. We understand that any change to your therapy device can feel significant. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. 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. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. 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. We are committed to providing you information and resources for your own understanding, but also to help you communicate with your patients effectively and efficiently. Should affected devices be removed from service? No further products are affected by this issue. For example, spare parts that include the sound abatement foam are on hold. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. These could include transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment, or require medical intervention to preclude permanent impairment. Examples of potential risks include exposure to degraded sound abatement foam particles or exposure to chemical emissions from the sound abatement form material. As a result of extensive ongoing review, on June 14 . We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. You are about to visit a Philips global content page. As a result, testing and assessments have been carried out. 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. Us to let us know you are a patient who has been to. Can also call ( 0044 ) 20 8089 3822 comprehensive repair and replace affected devices Respironics of a nationwide. Sound abatement foam are on hold ( 0044 ) 20 8089 3822 and! 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