By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. After you have registered your affected device, we will confirm your information by email prior to shipment and prepare to send your replacement. I have had sleep apnea and have used a CPAP machine for years. Can I buy one and install it instead of returning my 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. We know the profound impact this recall has had on our patients, business customers, and clinicians. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 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. This was initially identified as a potential risk to health. 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. You'll receive a new machine when one is available. 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. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. More information on the recall can be found via the links below. Donate to Apnea Board. 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. Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. 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. 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. 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. We will share regular updates with all those who have registered a device. We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. Please refer tothe FDAs guidance on continued use of affected devices. 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. CPAP Machines & Masks, and Oxygen Concentrators - Services From . The best way to know if your device is included in the recall is to register your machine for the recall. After you have registered your affected device, we will confirm your information by email prior to shipment and prepare to send your replacement. Philips has provided this guide to help you: https://www.philipssrcupdate.expertinquiry.com/locate-serial-number Fill out the registration form at the bottom of this page: https://www.philipssrcupdate.expertinquiry.com/ The list of, If their device is affected, they should start the. 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*. 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. Determining the number of devices in use and in distribution. https://www.mdl3014preservationregistry.com. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. What happens after I register my device, and what do I do with my old device? The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit. Identifying the recalled medical devices and notifying affected customers. Several Philips ventilators, CPAP and BiPAP machines were recalled in June 2021. 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. As a result, testing and assessments have been carried out. You are about to visit a Philips global content page. 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. Please click, We know how important it is to feel confident that your therapy device is safe to use. 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. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Call 1-877-907-7508. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used. 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 . Where can I find updates regarding patient safety? 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. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. All patients who register their details will be provided with regular updates. In the US, the recall notification has been classified by the FDA as a Class I recall. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. 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 . They do not include user serviceable parts. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. 2. Please be assured that we are working hard to resolve the issue as quickly as possible. 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. Koninklijke Philips N.V., 2004 - 2023. Please review the DreamStation 2 Setup and Use video for help on getting started. Philips Respironics will continue with the remediation program. Philips Respironics Sleep and Respiratory Care devices. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. If your device is an affected CPAP or bi-Level PAP unit: 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. 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 For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. 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. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Philips CPAP lawsuit settlements may be available for injuries linked to toxic foam in the sleep apnea machines. We are not taking new orders at this time, and we have stopped all new shipments temporarily, in order to support the field safety notice. 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. December 2022 update on completed testing for first-generation DreamStation devices, Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients, Jan Bennik, Head of Test and Research Program, explains the details behind the testing results, 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. 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. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. The FDA recognizes that many patients have questions about what this information means for the status of their devices. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. What is the potential safety issue with the device? Attempts to remove or change the sound abatement foam may render the device permanently inoperative and create health hazards. She traces a decline in her health to a Philips CPAP she began using in 2014. Repairing and replacing the recalled devices. You can view: safety recalls that have not been checked or fixed. As a first step, if your device is affected, please start the registration process here. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used. 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. 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. 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. We understand that this is frustrating and concerning for patients. 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. You'll get a confirmation number during the registration process. The American Academy of Sleep Medicine provides important safety information for patients about the Philips recall of certain PAP devices.