If you have a secondary back up device, switch over to that device. 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. 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. To register your product, you'll need to log into you're my Philips account. After registration, we will notify you with additonal information as it becomes available. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. For Spanish translation, press 2; Para espaol, oprima 2. . Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. We know how important it is to feel confident that your therapy device is safe to use. 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. 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. When will the correction for this issue begin? If your physician determines that you must continue using this device. 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. The new material will also replace the current sound abatement foam in future products. 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. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Are customers entitled to warranty replacement, repair, service or other mitigations? Formal discovery has started, and it isexpected to continue throughout 2023 and beyond, SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. Register your device at the Phillips Respironics website (link below). Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. You are about to visit a Philips global content page. The list ofaffected devices can be found here. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. What is the advice for patients and customers? Will existing patient devices that fail be replaced? 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. Can Philips replace products under warranty or repair devices under warranty? By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. The complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. At the bottom of the page, select "I am a Patient/Device User/Caregiver". 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. On June 14, Philips issued a recall for many of its CPAP, BiPAP and ventilator machines because of concerns that users may inhale small particles of the foam used to dampen sound while the machines are in use. 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. 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. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. Talk with health care providers to decide if your care and treatment should change as a result of this recall. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Philips Australia will work with your clinical care team to arrange a loan device, where required. To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected by the corrective action. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. For more information about your replacement device including video instructions click here. You are about to visit a Philips global content page. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Replace these devices with an unaffected device. Philips may work with new patients to provide potential alternate devices. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway. Please note that some people will also receive a copy of the Notice by email or post. Affected devices may be repaired under warranty. See all support information UPDATENovember 6, 2022: After further review of medical device reports, the FDA has revised the list of potential risks associated with this recall in the section, Reason for Recall. A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. 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 www.philips.com/SRC-update. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . CHEST Issues Joint Statement in Response to Philips Device Recall . (0044) 20 8089 3822 Physicians and other medical care providers Updating everyone on what they need to know and do, and to participate in the corrective action. Why did Philips issue the global recall notification in June 2021? 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. Please note that the information available at these links has not been separately verified by Philips Australia. Philips CPAPs cannot be replaced during ship hold. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Register your device (s) on Philips' recall website . Distribution Dates: August 6, 2020, to September 1, 2021, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. 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