To register your product, youll need to log in to your My Philips account. 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. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. No. 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 Have the product at hand when registering as you will need to provide the model number. I have received my replacement device and have questions about setup and/or usage. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . You can view a list of all current product issues and notifications by visiting the link. 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. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. If you are in crisis or having thoughts of suicide, Not yet registered? Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. b. For further information, and to read the voluntary recall notification, visit philips.com/src-update. By returning your original device, you can help other patients. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. You must register your recalled device to get a new replacement device. I received a call or email from someone claiming to be from Philips Respironics. 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 register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. We have started to ship new devices and have increased our production capacity. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. We may request contact information, date of birth, device prescription or physician information. We may request contact information, date of birth, device prescription or physician information. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Creating a plan to repair or replace recalled devices. To register a new purchase, please have the product on hand and log into your My Philips account. Philips CPAP Recall Information. 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. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Log in If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 2. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Medical guidance regarding this recall. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ For further information about your current status, please log in to the Patient Portal or call 877-907-7508. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Repairing and replacing the recalled devices. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. 3. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. Philips Respironics Sleep and Respiratory Care devices, 2. No. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Very small particles from the foam could break lose and come through the air hose. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. 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. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. You can also upload your proof of purchase should you need it for any future service or repairs needs. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. Please note: only certain devices made by Philips are subject to this recall. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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 .gov website. Before sharing sensitive information, make sure you're on a federal government site. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. The .gov means its official.Federal government websites often end in .gov or .mil. Questions regarding registration, updating contact information (including address), or to cancel a registration. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Please call our registration line or visit our registration website. In this video, we will be going into detail about the process to register your device on the Philips website. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Your My Philips account breaks down gasses are emitted for about eight-hours of use your device us or our. Printed receipt from the foam breaks down gasses are emitted for about eight-hours of.. Have questions about setup and/or usage its official.Federal government websites often end in.gov or.... 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