Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. You are about to visit a Philips global content page. We understand that any change to your therapy device can feel significant. For example, spare parts that include the sound abatement foam are on hold. Please refer tothe FDAs guidance on continued use of affected devices. Call 602-396-5801 For Next Steps. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. Status of cpap replacement. 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. They can help you if you have questions about how to use your replacement device and can troubleshoot and document issues you may be having. Learn more about Philips products and solutions for healthcare professionals. We are dedicated to working with you to come to a resolution. September 02, 2021. 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. To read more about ongoing testing and research, please click here. If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. Philips Respironics did not have conclusive data indicating that exposure to the particulates or emitted chemicals would lead to cancer. We will share regular updates with all those who have registered a device. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Please contact Patient Recall Support Team (833-262-1871). This is a potential risk to health. The .gov means its official.Federal government websites often end in .gov or .mil. Keep your registration confirmation number. 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. 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). We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. by MariaCastro Wed Mar 23, 2022 11:06 pm. Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. 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. 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. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. Based on the extensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Can I trust the new foam? 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. Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. To read more about ongoing testing and research, please click here. The DME supplier can check to see if your device has been recalled. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. As part of the remediation, we are offering repair or replacement of affected devices free of charge. We are producing and shipping similar CPAP, BiLevel PAP and Mechanical Ventilator platforms with a different design. The potential issue is with the foam in the device that is used to reduce sound and vibration. 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. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. The recall and health risks have led people with sleep apnea to find Philips CPAP alternatives. 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*. 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. Simply forward any receipts you have to recalls@donotpay.com, and we'll scan them against our updated list of recalled items. Please click here for the latest testing and research information. By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. We are producing and shipping similar CPAP, BiLevel PAP and Mechanical Ventilator platforms with a different design. Posts: 3485. 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. 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. Entering your device's serial number during registration will tell you if it is one of the recalled models . The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. As a CPAP recall drags on, sleep apnea sufferers are getting angry. We understand that this is frustrating and concerning for patients. In some cases, this foam showed signs of degradation (damage) and chemical emissions. 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. After you have registered your affected device, we will confirm your information by email prior to shipment and prepare to send your replacement. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Frequently updating everyone on what they need to know and do, including updates on our improved processes. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series), Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US), Also known as BiPAP V30 Auto Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. As soon as we receive the device, we replace the sound abatement foam and associated air pathway blower with brand new parts. 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. 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. 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. As a first step, if your device is affected, please start the, 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 replacement reinstates the two-year warranty. 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. Patients who have already registered their recalled machine with Philips can check the status of their recall at the Philips Recall Portal; Additional Actions. This recall notification comes more than a month after Philips . The FDA recognizes that many patients have questions about what this information means for the status of their devices. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Note that this will do nothing for . Foam: Do not try to remove the foam from your device. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Sleep apnea is a medical condition that affects an estimated 22 million Americans. "It's just as effective as a regular CPAP device. 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). 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. 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. What is considered a first generation DreamStation device? On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. In some cases, this foam showed signs of degradation (damage) and chemical emissions. 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 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. Phone. Where can i find out the status os my replacement. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. All rights reserved. [2] The remaining affected devices for remediation in the US can be found at www.philips.com/src-update. 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 Disclaimers * Voluntary recall notification in the US/field safety notice for the rest of the world. What is the advice for patients and customers? How long will I have to wait? Stopping treatment suddenly could have an immediate and detrimental effect on your health. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. It is important that you do not stop using your device without discussing with your doctor. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). The site is secure. On May 24, Philips Respironics issued a press release that provides additional context and information on the filed MDRs. Phillips Respironics, a maker of respirators and CPAP machines, has recalled several CPAP breathing . CPAP machines deliver a continual stream of filtered and pressurized air into a patient's airway to hold the. We do not offer repair kits for sale, nor would we authorize third parties to do so. More information on the recall can be found via the links below. 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 . On June 14, 2021, multinational health technology company Philips announced that it would be recalling CPAP and ventilator devices. That's why it came as a shock when Philips Respironics announced a voluntary recall of more than 15 million devices in June. 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. To register by phone or for help with registration, call Philips at 877-907-7508. The company said degraded PE-PUR foam may release black particles and toxic gasses that users may inhale or swallow. We know the profound impact this recall has had on our patients, business customers, and clinicians. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Ozone cleaners may exacerbate the breakdown of the foam, and . As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. You can also use the website to look up serial numbers and read instructions on how to register your device with Philips. Phone. If you have received your replacement device and need assistance to set it up, visit the Philips website for support. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Check if a car has a safety recall. Please click here for the latest testing and research information. 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. You can find the list of products that are not affected here. You can then start to reassemble your replacement device with the accessories you had been using, or new accessories. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. 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. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. 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. 1-800-542-8368. Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Repair and Replacement The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. A recall was issued on 17 million sleep apnea masks manufactured by Philips that contain magnetic clips. [FOR WEB] Please scroll down to view photos of affected devices if you are unsure which device you currently use. For example, spare parts that include the sound abatement foam are on hold. We will keep the public informed as more information becomes available. How many patients are affected by this issue? Do not stop using your device without speaking to your physician or care provider. Additionally, we remind both 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. It's super easy to upload, review and share your cpap therapy data charts. A Philips CPAP recall lawsuit seeks class action status, saying the manufacturer has failed to repair or replace the expensive machines, which contain a toxic foam that could cause respiratory . It is crucial to know if you must stop using your CPAP due to a medical device recall. I have been waiting for the replacement of my CPAP and no one has ever contacted me or email. Devices affected by the recall / field safety notice must be serviced only by qualified technicians. They are not approved for use by the FDA. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The potential issue is with the foam in the device that is used to reduce sound and vibration. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please be assured that we are working hard to resolve the issue as quickly as possible. Koninklijke Philips N.V., 2004 - 2023. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Patients who are concerned should check to see if their device is affected. Before opening your replacement device package, unplug your affected device and disconnect all accessories. The American Academy of Sleep Medicine provides important safety information for patients about the Philips recall of certain PAP devices. We know how important it is to feel confident that your therapy device is safe to use. CHIPPEWA FALLS, Wis. (WEAU) -Around 20 different models of ventilators, CPAP and BiPAP machines made by Philips were recalled in June because a foam inside . As a result, testing and assessments have been carried out. The Food and Drug Administration (FDA) has authorized Philips to start repairing the first-generation DreamStation sleep apnea machines that were recalled in June because foam used in the devices posed health issues to consumers. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Please review the DreamStation 2 Setup and Use video for help on getting started. When can Trilogy Preventative Maintenance be completed? 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. Locate that and on that label, there will be a series of numbers that follow a SN or S/N pattern. As a first step, if your device is affected, please start the registration process here.