Philips Australia will work with your clinical care team to arrange a loan device, where required. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio. High heat and high humidity environments may also contribute to foam degradation in certain regions. 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. Philips Sleep and respiratory care. You are about to visit the Philips USA website. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. At this time, affected devices are on manufacturing and ship hold. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Patients who are concerned should check to see if their device is affected by the corrective action. Can we help? 4. 1. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 2) the PE-PUR foam may off-gas certain chemicals. We thank you for your patience as we work to restore your trust. As a first step, if your device is affected, please start the. On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. In those regions where Philips provides both patient care and devices, will new patients be set up with 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. 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. 1800-28-63-020. Please note, the correction for Trilogy 100 is currently on hold. 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. 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. 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 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. 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. Call us at +1-877-907-7508 to add your email. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. As a first step, if your device is affected, please start theregistration process here. Once you receive your replacement device, you will need to return your old device. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. * Voluntary recall notification in the US/field safety notice for the rest of the world. This information has not been separately verified by Philips Electronics Australia Ltd. Is this a recall? Is Philips certain that this issue is limited to the listed devices? 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. 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 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Follow those instructions. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. We thank you for your patience as we work to restore your trust. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. 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. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Koninklijke Philips N.V., 2004 - 2023. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. However, this new recall does apply to some of the devices recalled . Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (International markets) / voluntary recall notification (U.S. only). We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. The return shipment for your old device is pre-paid so there is no charge to you. In the event of exposure to degraded foam: 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. Images may vary. See all support information At this time, Philips is unable to set up new patients on affected devices. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Philips Respironics initiated a voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices. The FDA has identified this as a Class I recall, the most serious type of recall. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Consult with your physician as soon as possible to determine appropriate next steps. Always ensure you are being taken care of, i.e. Are affected devices safe for use? Before sharing sensitive information, make sure you're on a federal government site. 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. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. Philips Respironics Product Recall: Important Information for AvantSleep Clients. For more information about your replacement device including video instructions click here. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 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: RecallPrescriptions@philips.com PAP Recall Guidance 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. No further products are affected by this issue. We are in touch with relevant customers and patients. 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. 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. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. The return shipment for your old device is pre-paid so there is no charge to you. The new material will also replace the current sound abatement foam in future products. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. The application for discontinuance will be heard by the Federal Court on 3 April 2023. You are about to visit a Philips global content page. You are about to visit a Philips global content page. At the bottom of the page, select "I am a Patient/Device User/Caregiver". 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* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. The .gov means its official.Federal government websites often end in .gov or .mil. You can find the list of products that are not affected as part of the corrective actionhere. Was it a design, manufacture, supplier or other problem? This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. The following updates in relation to device testing have been released by Philips RS North America on this webpage: Please note that the Philips RS North America website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia. Discuss the best treatment course with the patient. Don't have one? What is meant by "high heat and humidity" being one of the causes of this issue? See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Selected products Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. We thank you for your patience as we work to restore your trust. 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. Koninklijke Philips N.V., 2004 - 2023. Are you still taking new orders for affected products? We thank you for your patience as we work to restore your trust. Follow those instructions. 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 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. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. However, this new recall does apply to some of the devices recalled in June 2021. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: 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. 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. An official website of the United States government, : This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. *Note*: You can also call 877-907-7508 to register your device. 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. Philips Sleep and respiratory care. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Do not stop or alter your prescribed ventilator therapy. This recall notification / field safety notice has not yet been classified by regulatory agencies. Can I trust the new foam? What devices have you already begun to repair/replace? Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. Plaintiffsfiled a Second Amended Complaint in November 2022. How are you removing the old foam safely? Philips will provide further information regarding warranty replacement procedures during this issue when it is available. 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. CHEST MEMBERSHIP About Membership . Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. (0044) 20 8089 3822 Physicians and other medical care providers Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US 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. 3. Always ensure you are being taken care of, i.e. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. 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. 14841488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz. . Call 1800-28-63-020 if you cannot visit the website or do not have internet access. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. 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. Patient safety is our top priority, and we are committed to supporting our . Updating everyone on what they need to know and do, and to participate in the corrective action. 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. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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). 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. Contact your clinical care team to determine if a loan device is required. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. What is the advice for patients and customers? Philips Australia will work with your clinical care team to arrange a loan device, where required. At the bottom of this website, click Patient/Device User . Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. kidneys and liver) and toxic carcinogenic affects. Philips CPAPs cannot be replaced during ship hold. If you are a patient who has been affected by this correction, please 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 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. Contact your clinical care team to determine if a loan device is required. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. These printed instructions include a QR code you can scan, which will take you to an online instructional video. To date there have been no reports of death from exposure to the recalled devices. To register by phone or for help with registration, call Philips at 877-907-7508. This factor does not refer to heat and humidity generated by the device for patient use. Should affected devices be removed from service? Stopping treatment suddenly could have an immediate and detrimental effect on patient health. We thank you for your patience as we work to restore your trust. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Philips Australia will work with your clinical care team to arrange a loan device, where required. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected 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 contacts included Durable Medical Equipment (DME) suppliers. 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. 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