The devices are used to help breathing. They are undetectable after 24 hours of use. 2. Create account Create an account Already have an account? Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. My issue is not addressed here. a. You can also upload your proof of purchase should you need it for any future service or repairs needs. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. You can also visit philips.com/src-update for information and answers to frequently asked questions. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. The site is secure. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. To register your product, youll need to. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. Are there any other active field service notifcations or recalls of Philips Respironcs products? You must register your recalled device to get a new replacement device. 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 Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. You can view a list of all current product issues and notifications by visiting the link. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Please switch auto forms mode to off. %%EOF
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The full report is available here. Determining the number of devices in use and in distribution. 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. What information do I need to provide to register a product? If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 2. *. The FDA recognizes that many patients have questions about what this information means for the status of their devices. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. In the US, the recall notification has been classified by the FDA as a Class I recall. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. . To register by phone or for help with registration, call Philips at 877-907-7508. 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. Koninklijke Philips N.V., 2004 - 2023. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. endstream
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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. Koninklijke Philips N.V., 2004 - 2023. Philips Respironics continues to monitor recall awareness for affected patients [1]. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). 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 information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. A locked padlock
Use another similar device that is not a part of this recall. 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. Membership. For further information about your current status, please log into the portal or call 877-907-7508. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. Share sensitive information only on official,
We will automatically match your registered device serial number back to our partner inventory registrations. 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. News and Updates> Important update to Philips US recall notification. Apologize for any inconvenience. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. Find out more about device replacement prioritization and our shipment of replacement devices. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 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. 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 . Not yet registered? 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. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP.
Our Prescription Team is required to review all prescriptions. Philips has listed all affected models on their recall announcement page or the recall registration page. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. The data collected will be used to help to prioritize remediation of those patients at higher risk. 287 0 obj
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The full report is available here. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Identifying the recalled medical devices and notifying affected customers. 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/ A .gov website belongs to an official government
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