Register your device on the Philips recall website or call 1-877-907-7508. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. 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. 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. Please review the DreamStation 2 Setup and Use video for help on getting started. The .gov means its official.Federal government websites often end in .gov or .mil. Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses . Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. 2. 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. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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). Philips Respironics has recently voluntarily recalled multiple models of CPAP machines, including BiPAP machines and ventilators due to newly discovered health risks. How Do I Know if I Have a Phillips Recalled CPAP Machine? If your device is an affected CPAP or bi-Level PAP unit: Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Once you are registered, we will share regular updates to make sure you are kept informed. We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. Please click here for the latest testing and research information. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Further testing and analysis on other devices is ongoing. I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back. 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. 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. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. You do not need to register your replacement device. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Note that this will do nothing for . 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). The FDA recognizes that many patients have questions about what this information means for the status of their devices. The company said degraded PE-PUR foam may release black particles and toxic gasses that users may inhale or swallow. 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. Watch the video above. Philips Respironics did not have conclusive data indicating that exposure to the particulates or emitted chemicals would lead to cancer. Please click here for the latest testing and research information. As a first step, if your device is affected, please start the registration process here. What is the advice for patients and customers? Those clips have reportedly interfered with medical metallic implants or objects in the body such as pacemakers, cardioverter defibrillators and neurostimulators. 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. 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. 1-800-263-3342. 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. 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 . Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US The potential issue is with the foam in the device that is used to reduce sound and vibration. Philips Respironics Sleep and Respiratory Care devices. 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. How Do I Know if My CPAP Is Recalled? These repair kits are not approved for use with Philips Respironics devices. The DME supplier can check to see if your device has been recalled. If you are like most people, you will wake up when the CPAP machine stops. By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. 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. After five minutes, press the therapy button to initiate air flow. On May 24, Philips Respironics issued a press release that provides additional context and information on the filed MDRs. The Food and Drug Administration classified. 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 Philips recall website has a form for you to enter your device's serial number. 1-800-542-8368. Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. 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. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. Once Philips RS receives this information from your DME, we can continue to proceed with the remediation of your affected device. 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. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. 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). Register your device (s) on Philips' recall website or. We thank you for your patience as we work to restore your trust. 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. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. We will share regular updates with all those who have registered a device. Please visit theventilation news and updates pageforthe latest status of the Trilogy 100/200 remediation. Continuous positive airway pressure (CPAP) therapy is a common treatment for obstructive sleep apnea. In some cases, this foam showed signs of degradation (damage) and chemical emissions. "It's just as effective as a regular CPAP 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*. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. Can I buy one and install it instead of returning my device? Please click. You'll receive a new machine when one is available. Attempts to remove or change the sound abatement foam may render the device permanently inoperative and create health hazards. What happens when Philips receives recalled DreamStation devices? Please fill out the form below so a team member can get in touch with you in a timely manner. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. Locate that and on that label, there will be a series of numbers that follow a SN or S/N pattern. The American Academy of Sleep Medicine provides important safety information for patients about the Philips recall of certain PAP devices. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Please be assured that we are working hard to resolve the issue as quickly as possible. The potential issue is with the foam in the device that is used to reduce sound and vibration. When can Trilogy Preventative Maintenance be completed? By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. Check if a car has a safety recall. 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. See the FDA Safety Communication for more information. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. When you receive your replacement device, please first be sure to review all written instructions for setup, cleaning of existing components, and return instructions. Where can i find out the status os my replacement. Common problems with CPAP include a leaky mask, trouble falling asleep, a stuffy nose and a dry mouth.