When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. September 02, 2021. 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 do not offer repair kits for sale, nor would we authorize third parties to do so. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. But even if you don't, you'll be fine. Register your device on the Philips recall website or call 1-877-907-7508. Philips Respironics has recently voluntarily recalled multiple models of CPAP machines, including BiPAP machines and ventilators due to newly discovered health risks. Are spare parts currently part of the ship hold? Your prescription pressure should be delivered at this time. During the recertification process for replacement devices, we do not change the device serial number or model number. CDRH will consider the response when it is received. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. It is crucial to know if you must stop using your CPAP due to a medical device recall. So, for folks considering a travel device anyway, this might be a good strategy until the recalled . Where do I find my device's serial number? Working to reach everyone affected so they understand the situation and know what they need to do, starting with the registration of the affected devices. About Royal Philips This could affect the prescribed therapy and may void the warranty. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. How to Check if Your CPAP Was Recalled If you aren't sure if your Philips CPAP machine is included in the recall, you can check the Philips website to see pictures of recalled machines. If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. This also includes an in-depth review and re-assessment of data and toxicological risk-assessments prior to June 2021. 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. This was initially identified as a potential risk to health. Please click here for the latest testing and research information. Since then, together with five independent, certified testing laboratories in the US and Europe and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds. Further testing and analysis on other devices is ongoing. My replacement device isnt working or I have questions about it. Contact them with questions or complaints at 1-888-723-3366 . 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 The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. You are about to visit the Philips USA website. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Please be assured that we are doing all we can to resolve the issue as quickly as possible. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use. A recall was issued on 17 million sleep apnea masks manufactured by Philips that contain magnetic clips. They are encouraging everyone to register their device with Philips Respironics on their website or call 877-907-7508. We understand that any change to your therapy device can feel significant. After you have registered your affected device, we will confirm your information by email prior to shipment and prepare to send your replacement. Truckers for a Cause sleep apnea support group co-founder Bob Stanton commented during the meeting, noting that the cost of oral appliance therapy ends up being around $4,500 due to the appliance . The DME supplier can check to see if your device has been recalled. In some cases, this foam showed signs of degradation (damage) and chemical emissions. If you use a Philips Respironics CPAP or BiPAP device, like a Dream Station or System 1, continue to use your device as prescribed. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. All patients who register their details will be provided with regular updates. We strongly recommend that customers and patients do not use ozone-related cleaning products. As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. Before sharing sensitive information, make sure you're on a federal government site. Yes, Philips has recalled some of its ventilators, CPAP and BiPAP machines. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. 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. 1-800-229-6417 option 1. How do i register for prioritize replacement due to chronic health issues. We expect that we will have completed the repair and replacement program by the end of 2022 for the vast majority of patients. 1-800-263-3342. It is also important that your DME provider work with Philips RS to ensure that we have the information required to be able to send you your replacement device. 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 . This is a potential risk to health. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. On May 24, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement 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. Sincerely, The Medicare Team. Please click here for the latest testing and research information. If you have received your replacement device and need assistance to set it up, visit the Philips website for support. Published: Aug. 2, 2021 at 3:14 PM PDT. Patients who have already registered their recalled machine with Philips can check the status of their recall at the Philips Recall Portal; Additional Actions. Phillips Respironics, a maker of respirators and CPAP machines, has recalled several CPAP breathing . This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Ive received my replacement device. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. We thank you for your patience as we work to restore your trust. We understand that this is frustrating and concerning for patients. Sleep apnea is a medical condition that affects an estimated 22 million Americans. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. How long will I have to wait? 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. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. Philips Respironics guidance for healthcare providers and patients remains unchanged. If you are used to using a DreamStation CPAP device and have received a new DreamStation 2 CPAP Adanced, this new device has also been set to the same prescription settings as before and is ready for use. All rights reserved. Learn more about Philips products and solutions for healthcare professionals. Check the list of devices lower on this page to see if your device is affected by this action. 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 different, silicone foam. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. For Spanish translation, press 2; Para espaol, oprima 2. Once Philips RS receives this information from your DME, we can continue to proceed with the remediation of your affected device. Posts: 3485. Please be assured that we are working hard to resolve the issue as quickly as possible. As part of our commitment to quality and patient safety, Philips Respironics is dedicated to removing product containing the affected sound abatement foam from the market. Where can i find out the status os my replacement. Where can I find updates regarding patient safety? The potential issue is with the foam in the device that is used to reduce sound and vibration. 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. If you have been using a CPAP or medical device included in the recall, you should: Locate your serial number. Half of those devices are in use in the U.S., the company said . If you are like most people, you will wake up when the CPAP machine stops. You can find the list of products that are not affected, 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. If you have a DME and have not already, please contact notify them that they need to register your affected device serial number so that we can match you to your DME and continue the process. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used. What devices have you already begun to repair/replace? Philips recalled its CPAP, BiPAP and ventilator devices in June 2021 because of potential health risks. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. The recalled CPAP and BiPAP (also known as Bilevel PAP) therapy clips are used . Patients who are concerned should check to see if their device is affected. The list of, If their device is affected, they should start the. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. They are not approved for use by the FDA. As a first step, if your device is affected, please start the registration process here. Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 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. 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. 1-800-542-8368. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. If you have not yet been in contact with a representative from Philips Respironics, contact them directly at 877-907-7508 or register your machine at https://www.usa.philips.com . As part of the remediation, we are offering repair or replacement of affected devices free of charge. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. This is a potential risk to health. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Please fill out the form below so a team member can get in touch with you in a timely manner. On May 24, Philips Respironics issued a press release that provides additional context and information on the filed MDRs. To read more about ongoing testing and research, please click here. In May 2022, the FDA updated their safety communication to provide information on Medical Device Reports (MDRs) related to the Philips Respironics recall. As part of our commitment to quality and patient safety, Philips Respironics is dedicated to removing product containing the affected sound abatement foam from the market. A CPAP machine uses a hose connected to a mask or nosepiece to deliver constant and steady air pressure to help you breathe while you sleep. 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. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks.