Please note, the correction for Trilogy 100 is currently on hold. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. Can we help? The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). 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. 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. 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. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. We are in touch with relevant customers and patients. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. December 2, 2021 (latest update) . 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. Call us at +1-877-907-7508 to add your email. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. How will Philips address this issue? The return shipment for your old device is pre-paid so there is no charge to you. What is the cause of this issue? Please note that some people will also receive a copy of the Notice by email or post. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. Philips Sleep and respiratory care. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Affected devices may be repaired under warranty. Philips Australia will work with your clinical care team to arrange a loan device, where required. Always ensure you are being taken care of, i.e. If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. Particles or other visible issues? Leandro Mazzoni Head of Investor Relations, Rashiq Muhaimen Investor Relations Manager ESG related topics, Investor Relations Manager ESG related topics, Monique van der Heiden Corporate Access Manager. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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. 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. Before sharing sensitive information, make sure you're on a federal government site. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. 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. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). CHEST MEMBERSHIP About Membership . This recall notification / field safety notice has not yet been classified by regulatory agencies. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Koninklijke Philips N.V., 2004 - 2023. 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. The affected products are identified in the tables below: A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), 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. 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. The following products listed are affected by the correction: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Information for Trilogy 100 patients with a repaired device. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. 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. The new material will also replace the current sound abatement foam in future products. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. This could affect the prescribed therapy. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Philips has been in full compliance with relevant standards upon product commercialization. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. The site is secure. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 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. We know how important it is to feel confident that your therapy device is safe to use. Philips CPAPs cannot be replaced during ship hold. How are you removing the old foam safely? This Alert was related only to Trilogy 100 ventilators that were repaired. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a claim if their unit is affected. Philips is notifying regulatory agencies in the regions and countries where affected products are available. Updating everyone on what they need to know and do, and to participate in the corrective action. 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. 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. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. 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. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. No further products are affected by this issue. Koninklijke Philips N.V., 2004 - 2023. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. 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. 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. Should affected devices be removed from service? 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 a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. . Once you receive your replacement device, you will need to return your old device. 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. Philips may work with new patients to provide potential alternate devices. 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