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. 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. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. At this time, Philips is unable to set up new patients on affected devices. Examples of potential risks include exposure to degraded sound abatement foam particles or exposure to chemical emissions from the sound abatement form material. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. Click the link below to begin our registration process. 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). 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. The LCSMK1 is for the Surefire ST-07 or UE-07 tape switch. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? All oxygen concentrators, respiratory drug delivery products, airway clearance products. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. We strongly recommend that customers and patients do not use ozone-related cleaning products. Domain. The Trilogy, as well as the components containing PE-PUR foam, have all been placed on hold, for potential risks as outlined in the sound abatement foam recall 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. 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. At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues. 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. To resolve this situation as quickly as we can, we are doing the following: 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. 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. What is the safety hazard associated with this issue? Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows: For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include: Stopping use of an affected device Using another similar device that is not part of the recall Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. Further testing and analysis is ongoing. Particles or other visible issues? Call 1800-220-778 if you cannot visit the website or do not have internet access. Further testing and analysis is ongoing Please note that it is important that you only use approved cleaning methods for our devices and masks, as. As a result, testing and assessments have been carried out. If you have not done so already, please click here to begin the device registration process. Bien qu' ce jour le taux de plaintes soit trs faible (0,03% en 2020), Philips lance tout de mme ce rappel pour assurer la scurit des patients. Using alternative treatments for sleep apnea. For patients using life-sustaining mechanical ventilator devices, they should not stop or change ventilator use until they have talked to their health care providers regarding factors including: 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 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. Or call us at: 1-800-345-6443, Options 4-6-1. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). We're here for you and are prepared to continue to support individuals who rely on airway clearance therapies like the Philips InCourage system or Philips Respironics CoughAssist T70. 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), Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US), Also known as BiPAP V30 Auto Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). Best Fixed-Pressure: 3B Medical Luna G3 CPAP Machine. At this time, Philips is unable to set up new patients on affected devices. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. As a result of extensive ongoing review, on June 14 . Updated as of 9/1/2021. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Register your device for recall at: https://www.philipssrcupdate.expertinquiry.com. 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. 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 (outsideU.S.) / voluntary recall notification (U.S. only). We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process. On December 8, 2022, Apria was notified by Philips Respironics of a new nationwide recall of these remediated Trilogy 100/200 ventilator devices. 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 will provide further information regarding warranty replacement procedures during this issue when it is available. Monday-Friday: 8am-8pm ET, except holidays. 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. 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. U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit www.philips.com/ds2-replacement for more information. A small percentage of machines have been confirmed to have a defect resulting in damage to an insulating foam within the blower unit. We strongly recommend that customers and patients do not use ozone-related cleaning products. 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. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS. 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. 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. 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. 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. 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. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Include exposure to chemical emissions from the sound abatement form material address all devices! 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