If you are a patient who has been affected by this recall, do not try to remove the foam from your device. By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. The guidance for healthcare providers and patients remains unchanged. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. Please visit theventilation news and updates pageforthe latest status of the Trilogy 100/200 remediation. The VA is sending notifications to all veterans who have been issued a device and doing what they can to spread the word about the recall. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. The potential issue is with the foam in the device that is used to reduce sound and vibration. Follow the manufacturers instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. 50 series CPAP Registered users are being contacted by Philips to confirm their details in the lead up to each device being corrected. The FDA recognizes that many patients have questions about what this information means for the status of their devices. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), 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 recall, do not try to remove the foam from your device. This is a potential risk to health. She traces a decline in her health to a Philips CPAP she began using in 2014. Using packing tape supplied, close your box, and seal it. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Philips Respironics will continue with the remediation program. Check the device registration and then the recall contact information page which contains a list and pictures of the recalled Philips CPAP machines. Once you are registered, we will share regular updates to make sure you are kept informed. About Royal Philips We're adding new CPAP machines to the platform every month so join our mailing list and we will let you know when. The best way to know if your device is included in the recall is to register your machine for the recall. See the FDA Safety Communication for more information. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . The following products listed are affected by the recall notification / field safety notice: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Also known as BiPAP Hybrid A30Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Note that this will do nothing for . Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam. For the latest information on remediation of Trilogy 100/200 please click here to visit our ventilation news and updates page. Donate to Apnea Board. The Philips CPAP recall in June 2021 affected millions of CPAP, BiPAP and ventilator devices. Philips will then confirm that your device is one of the recalled models and advise you about your next steps. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly. We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process. Owners or users of DreamStation 1 devices who wish to preserve their units for purposes of a lawsuit have the option of requesting preservation, either by Philips Respironics or by the user, through the Preservation Registry established by Philips Respironics. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. If they discover that their device is involved, they can take steps to seek treatment and potentially file a lawsuit against Philips for any related damages sustained. Please fill out the form below so a team member can get in touch with you in a timely manner. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. You must register your recalled device to get a new replacement device. Doing this could affect the prescribed therapy and may void the warranty. Please refer tothe, If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). Do not use ozone or ultraviolet (UV) light cleaners. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. We're committed to patient safety, and partnering with clinicians and customers to ensure we're doing all we can to help patients. On May 24, Philips Respironics issued a press release that provides additional context and information on the filed MDRs. Disclaimers * Voluntary recall notification in the US/field safety notice for the rest of the world. The potential issue is with the foam in the device that is used to reduce sound and vibration. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. After you have registered your affected device, we will confirm your information by email prior to shipment and prepare to send your replacement. Learn more about Philips products and solutions for healthcare professionals. You can also use the website to look up serial numbers and read instructions on how to register your device with Philips. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. To read more about ongoing testing and research, please click here. This Philips Respironics December 2022 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for VOCs, particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products. Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. The testing information published in December 2022 was performed on the original DreamStation device and applies to DreamStation, DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, DreamStation BiPAP ASV, and E30 ventilator devices. What happens after I register my device, and what do I do with my old device? Devices affected by the recall / field safety notice must be serviced only by qualified technicians. So, for folks considering a travel device anyway, this might be a good strategy until the recalled . On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. Philips CPAP lawsuit settlements may be available for injuries linked to toxic foam in the sleep apnea machines. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). A recall was issued on 17 million sleep apnea masks manufactured by Philips that contain magnetic clips. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page.