Do affected units exhibit features that customers / users should watch out for? 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. The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. * Voluntary recall notification in the US/field safety notice for the rest of the world. If you have a secondary back up device, switch over to that device. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Always ensure you are being taken care of, i.e. 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. 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. 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. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. This factor does not refer to heat and humidity generated by the device for patient use. At this time, Philips is unable to set up new patients on affected devices. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. Philips has been in full compliance with relevant standards upon product commercialization. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. We thank you for your patience as we work to restore your trust. The products were designed according to, and in compliance with, appropriate standards upon release. The site is secure. 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. Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air Medical Device recall notification (U.S. only) / field safety notice (International Markets). This recall notification / field safety notice has not yet been classified by regulatory agencies. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. To resolve this situation as quickly as we can, we are doing the following: 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. 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. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, was corrected or replaced through the June 2021 recall, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, report adverse reactions or quality problems, Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. When will the correction for this issue begin? Click "Next". 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. 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. Images may vary. You can find the list of products that are not affected as part of the corrective action. We know how important it is to feel confident that your therapy device is safe to 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. Philips may work with new patients to provide potential alternate devices. Will existing patient devices that fail be replaced? Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. For more information click here. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. 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. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Once you receive your replacement device, you will need to return your old device. 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. 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). 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. Contact your clinical care team to determine if a loan device is required. If you have not done so already, please click here to begin the device registration process. How will Philips address this issue? Click the link below to begin our registration process. 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. The letter offered the following recommendations. 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. The company has developed a comprehensive plan for this correction, and has already begun this process. For more information about your replacement device including video instructions click here. 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. The application for discontinuance will be heard by the Federal Court on 3 April 2023. 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. 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. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Should affected devices be removed from service? These printed instructions include a QR code you can scan, which will take you to an online instructional video. 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 We thank you for your patience as we work to restore your trust. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). 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. Have regulatory authorities classified the severity of the recall? Where do I direct questions about my replacement device? Please read the Notice carefully. Koninklijke Philips N.V., 2004 - 2023. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. It includes further information such as what steps are available to Group Members in the class action. 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). The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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. You can register here. 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. 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). We are in touch with relevant customers and patients. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. [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. 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. . Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. This recall notification / field safety notice has not yet been classified by regulatory agencies. 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. 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. This potentially deadly combination . How it works. 2. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Follow those instructions. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. The list ofaffected devices can be found here. 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. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. 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. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. 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. Please note that the information available at these links has not been separately verified by Philips Australia. If you have not done so already, please click here to begin the device registration process. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. With relevant standards upon product commercialization Federal Court on 3 April 2023 for discontinuance will be heard by the Court. The sound abatement foam that is the leading provider of innovative solutions for global. 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