Contact your clinical care team to determine if a loan device is required. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? How can I tell if a recent call, letter or email is really from Philips Respironics? Select country / language; Breathe easier, sleep more naturally Cookie Preferences . As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. The products were designed according to, and in compliance with, appropriate standards upon release. 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. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. You can access the Philips RS North America webpage by clicking here. 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. At this time, affected devices are on manufacturing and ship hold. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Don't have one? 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 (Internationalmarkets) / voluntary recall notification (U.S. only). The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Replace these devices with an unaffected device. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. Register your device at the Phillips Respironics website (link below). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. Before sharing sensitive information, make sure you're on a federal government site. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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. Affected devices may be repaired under warranty. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). 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. 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. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. Philips CPAPs cannot be replaced during ship hold. Images may vary. Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use., In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. This recall notification / field safety notice has not yet been classified by regulatory agencies. 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. What happens after I register my device, and what do I do with my old device? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). If you do not have this letter, please call the number below. 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. Koninklijke Philips N.V., 2004 - 2023. This factor does not refer to heat and humidity generated by the device for patient use. 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). However, this new recall does apply to some of the devices recalled in June 2021. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Are you still taking new orders for affected products? 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. Philips CPAPs cannot be replaced during ship hold. 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. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Are spare parts currently part of the ship hold? Talk with health care providers to decide if your care and treatment should change as a result of this recall. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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 Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. We thank you for your patience as we work to restore your trust. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. 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. See all support information Have regulatory authorities classified the severity of the recall? (0044) 20 8089 3822 Physicians and other medical care providers 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 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). Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. The relevant subsidiaries are cooperating with the agency. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Create account Create an account The return shipment for your old device is pre-paid so there is no charge to you. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. We know how important it is to feel confident that your therapy device is safe to use. Doing this could affect the prescribed therapy. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. The letter offered the following recommendations. 1800-28-63-020. All rights reserved. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. This recall notification / field safety notice has not yet been classified by regulatory agencies. If you have not done so already, please click here to begin the device registration process. 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 correction process. Please note that the information available at these links has not been separately verified by Philips Australia. 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. Philips is notifying regulatory agencies in the regions and countries where affected products are available. Once you receive your replacement device, you will need to return your old device. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Plaintiffsfiled a Second Amended Complaint in November 2022. 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. 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. For more information about your replacement device including video instructions click. 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. 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. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). 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. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. We thank you for your patience as we work to restore your trust. 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 Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). 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. We thank you for your patience as we work to restore your trust. The plastic may also cause the machine to fail and stop working suddenly during use. The new material will also replace the current sound abatement foam in future products. Philips Quality Management System has been updated to reflect these new requirements. 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. 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. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Consult with your physician to determine the benefits of continuing therapy and potential risks. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Philips may work with new patients to provide potential alternate 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. For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider. Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. As a first step, if your device is affected, please start theregistration process here. 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. * Voluntary recall notification in the US/field safety notice for the rest of the world. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Philips has been in full compliance with relevant standards upon product commercialization. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The return shipment for your old device is pre-paid so there is no charge to you. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Philips Quality Management System has been updated to reflect these new requirements. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. Particles or other visible issues? At the bottom of this website, click Patient/Device User . 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. Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. The potential risks associated with this recall include: If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. Process Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers The FDA acknowledges that the submission of anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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 should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. If separation of the foam from the plastic backing was to occur, to the extent that therapy is impacted, your device will issue a High Priority alarm, either Low Inspiratory Pressure or Circuit Disconnect. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. You are about to visit the Philips USA website. Should affected devices be removed from service? 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 Patient safety is our top priority, and we are committed to supporting our . There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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