CDRH will consider the response when it is received. Medical Device Recall Information Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). We're committed to patient safety, and partnering with clinicians and customers to ensure we're doing all we can to help patients. Your apnea mask is designed to let you breathe room air if the continuous air stops. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. Simply forward any receipts you have to recalls@donotpay.com, and we'll scan them against our updated list of recalled items. The most serious CPAP injuries are likely to be cancer, organ damage, and respiratory problems. Before opening your replacement device package, unplug your affected device and disconnect all accessories. 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. 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. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. The latest information regarding this action can be found at our publicly available web site: https://www.philips.com/src-update. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. You can then start to reassemble your replacement device with the accessories you had been using, or new accessories. 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. 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. 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. 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. 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. Millions of Philips DreamStation, CPAP and BiPAP machines sold from 2009 to April 2021 have been recalled. We understand that any change to your therapy device can feel significant. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. How many patients are affected by this issue? These repair kits are not approved for use with Philips Respironics devices. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Status of cpap replacement. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. Register your device (s) on Philips' recall website or. Please click. Please click, We know how important it is to feel confident that your therapy device is safe to use. At the time, Philips Respironics could not exclude possible carcinogenic effects with the limited dataset that was available. We will share regular updates with all those who have registered a device. It does not apply to DreamStation Go. 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. After five minutes, press the therapy button to initiate air flow. Tillie O'Kelley with her current CPAP machine her bedroom in Arcadia, La. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. 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 . You can use the car registration number to check if it's been recalled. Disclaimers * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. Entering your device's serial number during registration will tell you if it is one of the recalled models . 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. She traces a decline in her health to a Philips CPAP she began using in 2014. You do not need to register your replacement device. 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. Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. We will provide updates as the program progresses to include other models. Contact them with questions or complaints at 1-888-723-3366 . The Philips recall website has a form for you to enter your device's serial number. 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. Philips recalled its CPAP, BiPAP and ventilator devices in June 2021 because of potential health risks. A voluntary recall of millions of CPAP breathing machines, used mainly to treat sleep apnea, has many users wondering if they've been inhaling cancer . Are you still taking new orders for affected products? During the recertification process for replacement devices, we do not change the device serial number or model number. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. [FOR WEB] Please scroll down to view photos of affected devices if you are unsure which device you currently use. By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. All rights reserved. We are focused on making sure patients and their clinicians have all the information they need. Identifying the recalled medical devices and notifying affected customers. 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. Using alternative treatments for sleep apnea. Register your device on the Philips recall website or call 1-877-907-7508. The potential issue is with the foam in the device that is used to reduce sound and vibration. 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. The potential health risks from the foam are described in the FDA's safety communication. 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 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 . After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. What do I do? We will share regular updates with all those who have registered a device. See How to Locate the Serial Number on your device on the Philips website. The recall also included many bilevel positive airway pressure (BiPAP) devices and ventilators designed to provide breathing assistance. Signs of an Aging CPAP Mask: CPAP Masks should be washed daily with warm water and gentle soap or baby shampoo. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. As a first step, if your device is affected, please start the registration process here. As a patient, if you have registered your device, but it has not been matched to a DME provider, there may be several reasons that this has occurred. This was initially identified as a potential risk to health. The .gov means its official.Federal government websites often end in .gov or .mil. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. 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.