Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Your prescription pressure should be delivered at this time. Do not stop using your device without speaking to your physician or care provider. We will provide updates as the program progresses to include other models. Disclaimers * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. My replacement device isnt working or I have questions about it. 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. 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. I have had sleep apnea and have used a CPAP machine for years. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Philips CPAP Recall Status Following the initial recall of Philips CPAP, BIPAP and ventilator machines in June 2021, predominantly from the DreamStation line of products, an additional recall was issued in October 2022. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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. Ive received my replacement device. We understand that this is frustrating and concerning for patients. fact In July 2021, the FDA classified the Philips CPAP recall as a Class I recall. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. You can then start to reassemble your replacement device with the accessories you had been using, or new accessories. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Because of this we are experiencing limited stock and longer than normal fulfillment times. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. 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. Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. Philips will then confirm that your device is one of the recalled models and advise you about your next steps. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. 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. Doing this could affect the prescribed therapy and may void the warranty. Phone. The company is currently working to repair and replace the affected devices. How do i register for prioritize replacement due to chronic health issues. Status of cpap replacement. Further testing and analysis on other devices is ongoing. Philips Respironics will continue with the remediation program. Sincerely, The Medicare Team. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. Are spare parts currently part of the ship hold? In some cases, this foam showed signs of degradation (damage) and chemical emissions. Once all accessories have been installed, plug in your device to a working wall outlet and wait five minutes for your device settings to upload. All patients who register their details will be provided with regular updates. When you receive your replacement device, please first be sure to review all written instructions for setup, cleaning of existing components, and return instructions. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. More information and instructions on how to register for preservation may be found at: https://www.mdl3014preservationregistry.com . This is a potential risk to health. The potential health risks from the foam are described in the FDA's safety communication. Devices affected by the recall / field safety notice must be serviced only by qualified technicians. As a result, testing and assessments have been carried out. Simply forward any receipts you have to recalls@donotpay.com, and we'll scan them against our updated list of recalled items. Please be assured that we are working hard to resolve the issue as quickly as possible. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used. Doing this could affect the prescribed therapy and may void the warranty. We're committed to patient safety, and partnering with clinicians and customers to ensure we're doing all we can to help patients. All oxygen concentrators, respiratory drug delivery products, airway clearance products. They are not approved for use by the FDA. Replace Your CPAP Mask Every 6 to 12 Months Getting the Most Out of Your CPAP Mask: Air leakage, loose headgear, general discomfort, frayed fabric, visible rips or tears in your cushion, loss of cushion shape. On June 14, 2021, Philips Respironics announced a voluntary recall of its Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP, and ventilator devices) that it manufactures, due to issues related to the sound abatement foam used in these devices. Please review the DreamStation 2 Setup and Use video for help on getting started. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Throughout the remediation of this recall we will provide guidance and share next steps so you can ensure you have the most current and accurate information. We then thoroughly clean and decontaminate the device, update the firmware, test, and repackage it with a recertified sticker to show that it is ready for use. It is important that you do not stop using your device without discussing with your doctor. The latest information regarding this action can be found at our publicly available web site: https://www.philips.com/src-update. The potential issue is with the foam in the device that is used to reduce sound and vibration. No- the replacement device you have received is not affected by the recall/ field safety notice, because the foam in the device has been replaced with a new type of foam. Philips CPAP lawsuit settlements may be available for injuries linked to toxic foam in the sleep apnea machines. More information on the recall can be found via the links below. In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. How are you removing the old foam safely? You can find the list of products that are not affected here. Common problems with CPAP include a leaky mask, trouble falling asleep, a stuffy nose and a dry mouth. We do not offer repair kits for sale, nor would we authorize third parties to do so. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. September 02, 2021. You do not need to register your replacement device. The DME supplier can check to see if your device has been recalled. Call 1-877-907-7508. Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution. Where can i find out the status os my replacement. We are focused on making sure patients and their clinicians have all the information they need. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. This could affect the prescribed therapy and may void the warranty. June 15, 2021 -- Dutch-based medical equipment maker Philips is recalling CPAP machines, ventilators, and other breathing devices because of concerns that sound-reducing foam on the devices can . The potential issue is with the foam in the device that is used to reduce sound and vibration. These repair kits are not approved for use with Philips Respironics devices. If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at https://www.mdl3014preservationregistry.com, Philips will not charge the users DME supplier for the cost of the replacement device. Locate that and on that label, there will be a series of numbers that follow a SN or S/N pattern. Are there any steps that customers, patients, and/or users should take regarding this issue? Published: Aug. 2, 2021 at 3:14 PM PDT. To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected. Register your device on the Philips website. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Once you are registered, we will share regular updates to make sure you are kept informed. For the latest information on remediation of Trilogy 100/200 please click. When can Trilogy Preventative Maintenance be completed? 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). This is a potential risk to health. They do not include user serviceable parts. This could affect the prescribed therapy and may void the warranty. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Using packing tape supplied, close your box, and seal it. You can read the press release here. I've been told that I am considered "not matched" to a DME and therefore Philips RS is unable to send me my replacement device. Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. Frequently updating everyone on what they need to know and do, including updates on our improved processes. You'll get a confirmation number during the registration process. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. 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. To resolve this situation as quickly as we can, we are doing the following: 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. If you are an established patient at Everything CPAP, know that we have already began the process of getting your machine fixed or replaced. Ankin Law Office Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. If you are still uncertain you can complete the registration process that allows you to look up the serial number of your device. 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. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. These are the numbers you will be needing to find out if the CPAP device that you are using is part of the Phillips recall. On June 14, 2021, Philips announced that it would be recalling three to four million continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and mechanical ventilator devices over risks associated with the products' sound abatement foam. 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 The most serious CPAP injuries are likely to be cancer, organ damage, and respiratory problems. You can read the press release, On May 24, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. Repair and Replacement Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. We know the profound impact this recall has had on our patients, business customers, and clinicians. 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 strongly recommend that customers and patients do not use ozone-related cleaning products. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. "The object in life is not to be on the side of the majority, but to escape finding oneself in the ranks of the insane." -- Marcus Aurelius. More information and instructions on how to register for preservation may be found at: It is important that you do not stop using your device without discussing with your doctor. 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. Individuals can check online through the Philips registry to find out whether their device is part of the CPAP recall. Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio. Patients who are concerned should check to see if their device is affected. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. You'll receive a new machine when one is available. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. Follow these instructions to get a new device: Register your device on the Philips Respironics websiteor call 877-907-7508. 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. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820).

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