On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Philips Respironics created an online registration process to allow patients to look up their device serial number . hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. There are no updates to this guidance. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 2. Philips CPAP Recall Information. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. No. Veterans Crisis Line: In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. Devices need to be registered with Philips Respironics to receive a replacement device. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, 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). News and Updates> Important update to Philips US recall notification. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. %PDF-1.7 % Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. Call us at +1-877-907-7508 to add your email. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. A .gov website belongs to an official government This will come with a box to return your current device to Philips Respironics. Philips has listed all affected models on their recall announcement page or the recall registration page. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. More information on. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Before sharing sensitive information, make sure you're on a federal government site. 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. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at [email protected]. Very small particles from the foam could break lose and come through the air hose. The relevant heath information that will be asked includes: An occupation associated with public safety. Membership. Attention A T users. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. Philips Respironics (Philips) voluntarily recalled certain 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. The foam cannot be removed without damaging the device. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. My prescription settings have been submitted, but I have not yet received a replacement. The FDA has reached this determination based on an overall benefit-risk assessment. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. If you have been informed that you can extend your warranty, first you need a My Philips account. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips Respironics continues to monitor recall awareness for affected patients [1]. Dont have one? Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. My issue is not addressed here. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Our Prescription Team is required to review all prescriptions. the .gov website. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Philips did not request a hearing at this time but has stated it will provide a written response. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive 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. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. CHEST MEMBERSHIP About Membership . Are people claiming to be registered with Philips Respironics continues to monitor recall awareness for patients... 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