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. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Foam: Do not try to remove the foam from your device. 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). Follow the recommendations above for the recalled devices used in health care settings. If you are in crisis or having thoughts of suicide, While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. 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. 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. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand 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. Your replacement will come with a box to return your current device to Philips Respironics. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. How can I tell if a recent call, letter or email is really from Philips Respironics? Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Creating a plan to repair or replace recalled devices. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. Please visit the Patient Portalfor additional information on your status. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. For further information about your current status, please log into the portal or call 877-907-7508. Call us at +1-877-907-7508 to add your email. The .gov means its official.Federal government websites often end in .gov or .mil. For Spanish translation, press 2; Para espaol, oprima 2. Then you can register your product. All rights reserved. There are currently no items in your shopping cart. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. To register a new purchase, please have the product on hand and log into your My Philips account. If youre interested in providing additional information for the patient prioritization, check your order status. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. 1. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Call us at +1-877-907-7508 to add your email. Well start processing your replacement device order once: 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. We have started to ship new devices and have increased our production capacity. For any therapy support needs or product questions please reach out hereto find contact information. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. ) or https:// means youve safely connected to 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 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. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. Apologize for any inconvenience. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. 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. News and Updates> Important update to Philips US recall notification. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Can we help? The site is secure. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. %%EOF Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Dont have one? By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Official websites use .gov I am experiencing technical issues with the Patient Portal. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. In this video, we will be going into detail about the process to register your device on the Philips website. You are about to visit a Philips global content page. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. CHEST MEMBERSHIP About Membership . Access all your product information in one place (orders, subscriptions, etc. 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. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. 2. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. 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. No. Be cautious as they may be scams! Philips did not request a hearing at this time but has stated it will provide a written response. Create account Create an account Already have an account? For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Images may vary. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. You can also upload your proof of purchase should you need it for any future service or repairs needs. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. My issue is not addressed here. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. VA clinical experts are working with the FDA and the manufacturer to understand those risks. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream A .gov website belongs to an official government Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. You can also visit philips.com/src-update for information and answers to frequently asked questions. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible.