Trying to or successfully removing the foam may damage the device or change how the device works. This replacement reinstates the two-year warranty. As part of our commitment to quality and patient safety, Philips is dedicated to removing product containing the affected sound abatement foam from the market. Are you still taking new orders for affected products? 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. You'll receive a new machine when one is available. 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. It may also lead to more foam or chemicals entering the air tubing of the device. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. How Do I Know if I Have a Phillips Recalled CPAP Machine? 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. Keep your registration confirmation number. 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. How long will I have to wait? Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. You can read the press release, We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. The .gov means its official.Federal government websites often end in .gov or .mil. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. It is crucial to know if you must stop using your CPAP due to a medical device recall. Sleep apnea is a medical condition that affects an estimated 22 million Americans. Please click, We know how important it is to feel confident that your therapy device is safe to use. It could take a year. We know how important it is to feel confident that your therapy device is safe to use. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Koninklijke Philips N.V., 2004 - 2023. 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. Before opening your replacement device package, unplug your affected device and disconnect all accessories. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. 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). How to check for recalls using DoNotPay's Product Recall Monitor: If you don't have a specific recalled product in mind yet, DoNotPay can check to see if any of your recent purchases have been recalled. CPAP Machines & Masks, and Oxygen Concentrators - Services From . Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows: For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include: Using another similar device that is not part of the recall. 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. They are encouraging everyone to register their device with Philips Respironics on their website or call 877-907-7508. In some cases, this foam showed signs of degradation (damage) and chemical emissions. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 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. 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. This could affect the prescribed therapy and may void the warranty. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Patients, physicians and durable medical equipment (DME) suppliers can call Philips at 877-907-7508 for additional support. These repair kits are not approved for use with Philips Respironics devices. The site is secure. We will share regular updates with all those who have registered a device. You can also use the website to look up serial numbers and read instructions on how to register your device with Philips. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. 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 . Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. 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. This recall includes certain devices that Apria provides to our patients. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. Using packing tape supplied, close your box, and seal it. 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). But even if you don't, you'll be fine. However, if the user is not in the Preservation Registry and fails to return his or her unit, then Philips may charge the users DME supplier for the cost of the replacement device. 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. It does not apply to DreamStation Go. I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. 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. Your apnea mask is designed to let you breathe room air if the continuous air stops. Immediately after the announcement of the recall, Everything CPAP worked with Philips to get serial numbers registered on their secure portal. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. The replacement device Ive received has the same model number as my affected device. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. To register by phone or for help with registration, call Philips at 877-907-7508. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. You can read the press release here. The potential issue is with the foam in the device that is used to reduce sound and vibration. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. We understand that this is frustrating and concerning for patients. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. If you are still uncertain you can complete the registration process that allows you to look up the serial number of your device. Creating a plan to repair or replace recalled devices. You should register any affected device through the website, Philips.com/src-update, or by phone at 1-877-907-7508. In addition, we are beginning the rework of affected Trilogy 100/200 devices at Philips Service Centers and designated remanufacturing sites in many markets. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. Register your device on the Philips website. We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. 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 remediation process. For the latest information on remediation of Trilogy 100/200 please click here to visit our ventilation news and updates page. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Because of this we are experiencing limited stock and longer than normal fulfillment times. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions.